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DBU - Medical FIA

We are a leading Manufacturer of ichroma ii immuno analyzer, sd biosensor standard f200 analyzer, ichroma progesterone test, ichroma psa test, ichroma hba1c test and f100 analyzer from Chennai, India.
Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer
  • Ichroma II Immuno Analyzer

Ichroma II Immuno Analyzer

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Product Brochure

Product Details:
Model Name/NumberIchroma II
BrandBoditech
ParametersCardiac, Hormone, Diabetic, Cancer, Infection And Vitamin D Special Parameter, Covid
AutomationSemi Automatic
User InputTouch
Power Supply220 V
Weight1.3 kg
Dimension276x220x91 mm
Display Screen7 inch Touch Screen
Cortridges:
Product Class
TEST ITEMPACK
CARDIAC

Tnl25
Hs Tnl Plus25
CK-MB25
D-Dimer25
Myoglobin25
hsCRP25
NT PRO BMP25
Cardiac Triple Marker-TnI/CK-MB /MyogIobin25
CANCER

PSA25
AFP25
CEA25
DIABETES

HbAlc25
Microalbumin25
Cystatin C25
HORMONE

TSH25
T325
T425
AMH 25
FSH25
Progesterone25
hCG25
B-hCG25
LH25
Prolactin25
Testosterone25
Cortisol25
AUTOIMMUNE

RF lgM25
Anti-CCP Plus25
Total lgE 25
INFACTION

CRP25
ProcaIcitonin10
Procalcitonin Plus 10
ASO25
Denque IgG/IgM25
Dengu e NS1 Ag25
Covid - 19 25
RESPIRATORY

Strep A 25
Influenza A+B25
GASTRO-
INTESTINE

ROTA 25
ROTA Adeno 25
NORONEW25
Calprotectin 25
Fob Neo25
OTHERS

Ferritin25
Vitamin D25
Controls1
System Chek Cartridge1
Knob capillary: HbAle1
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SD Biosensor Standard F200 Analyzer
  • SD Biosensor Standard F200 Analyzer
  • SD Biosensor Standard F200 Analyzer
  • SD Biosensor Standard F200 Analyzer
  • SD Biosensor Standard F200 Analyzer
  • SD Biosensor Standard F200 Analyzer

SD Biosensor Standard F200 Analyzer

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Product Details:
Model Name/NumberF200
BrandSD Biosensor
Usage/ApplicationLaboratory
Detection MethodFlourosence immunoassay
ParametersBlood Alcohol Content
AutomationSemi Automatic
User InputTouch
Weight4 kg
Product Details:-

Standard F200 is fluorescet immunoassay systems and have been designed for easy and reliable measuring of diverse items. Standard F200 provide LIS connectivity to connect the majority of existing information system in hospital. So it is good to use in hospital, clinic or small to medium size lab.
  • Europium-based fluorescent chemistry - Large Stoke’s shift permits sensitive fluorescence detection.
  • No-coding via 2D barcode system
  • Internal quality control
  • Simple and easy to use - Familiar lateral flow test platform.
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ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test
  • ichroma Progesterone Test

ichroma Progesterone Test

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Product Details:
BrandBoditech Med Incorporated
Size25 Test
SamplesSerum/Plasma
Recommended anticoagulantK2 EDTA, K3 EDTA, sodium heparin
Storage Temperature4 - 30 DegreeC
Cat NoCFPC-21
Progesterone

Monitoring ovulation abnormalities and predicting miscarriage & ectopic pregnancy

The progesterone test kit measures the level of progesterone in the blood. The progesterone test alone is not enough to diagnose a particular problem. But the result may help provide answers to causes of infertility, risk of miscarriage, ovulation, and ectopic pregnancy.

PRINCIPLE :

     The test uses a competitive immunodetection method. In this method, the analyte in the sample binds to the fluorescence labeled (FL) detection antibody in detection buffer, to form the complex as sample mixture. This complex is loaded to migrate onto the nitrocellulose matrix, where the covalent couple of progesterone and bovine serum albumin (BSA) is immobilized, and interferes with the binding of analyte and fluorescence labeled (FL) antibody. If more analytes exist in the sample, less detection antibodies are accumulated, resulting in less fluorescence signal. 

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ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test
  • ichroma PSA Test

ichroma PSA Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
Sampleswhole blood/serum/plasma
Sample volume75 Microliter
stored at4 - 30 DegreeC
Cat Noi CHROMA PSA-25
Prostate Specific Antigen (PSA)

Screening for the prostate cancer & monitoring the effects of the treatment

This test helps in the early detection of prostate diseases such as enlarged prostate and prostatitis and prostate cancer by quantifying PSA in male blood, as well as observation of treatment effects and monitoring of recurrence.


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ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test
  • ichroma HbA1c Test

ichroma HbA1c Test

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Product Details:
BrandBoditech Med Incorporated
Size25 Test
SamplesWhole blood
Sample volume75 Microliter
Cat NoCFPC-38
Storage Temperature4 - 30 DegreeC
HbA1c

Assessing the level of glycated hemoglobin in the blood

This test is certified by NGSP (National Glycohemoglobin Standardization Program). It helps diabetic diagnosis, treatment, and prognosis by measuring the glycated hemoglobin concentration (%) in a small amount of blood over the past 3 months.

INTENDED USE

ichroma™ HbA1c is a fluorescence Immunoassay (FIA) for the quantitative determination of HbA1c(Hemoglobin A1c) in human whole blood. It is useful as an aid in management and monitoring of the longterm glycemic status in patients with diabetes mellitus. For in vitro diagnostic use only.

PRINCIPLE:

The test uses a sandwich immunodetection method; the detector antibody in buffer binds to antigen in sample, forming antigen-antibody complexes, and migrates onto nitrocellulose matrix to be captured by the other immobilized-antibody on test strip. The more antigen in sample forms the more antigen-antibody complex and leads to stronger intensity of fluorescence signal on detector antibody. Instrument for ichroma™ tests displays the content of glycated hemoglobin in terms of percent of the total hemoglobin in blood.





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F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer
  • F100 Analyzer

F100 Analyzer

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Product Brochure

Product Details:
Instrument Nameimmunoassay device
BrandSD Biosensor
Power SupplyAC/DC adapter or Battery(AAx4)
Display TypeGraphic LCD
Dimensions105x135x100 mm
Cat. No10FA10
STANDARD FF100

STANDARD F100 Analyzer is a small fluorescence immunoassay device that can perform qualitative and quantitative analyses on infections, respiratory diseases and chronic diseases, and it is operable with battery.
Intented Use

This small fluorescence immunoassay device can perform qualitative and quantitative analysis on infections, respiratory diseases and chronic diseases, and it is operable with battery.
Advantage

  • Small size optimized for on-site diagnosis
  • Recognize information stored in 2D barcode
  • Internal quality control
  • Specification
    • INPUT 

      AC100~240V, 50/60Hz

    • Display 

      Graphic LCD

    • Power Consumption 

      Battery(AA x 4) & AC/DC adapter

    • LIS/HIS 

      Data transfer using Bluetooth function

    • Size 

      105 x 135 x 100 mm

    • Bar Code Scanner (Option) 

      USB Barcode Scanner

    • Weight 

      700g

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F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer
  • F2400 Analyzer

F2400 Analyzer

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Product Details:
Instrument NameImmunoassay device
BrandSD Biosensor
Power SupplyPower Cable (SMPS adapted)
Display Type10" Color Touch Screen
Dimensions510 x 566 x 297
Cat. No10FA24

F2400

STANDARD F2400 is a Fluorescent immunoassay system that uses fluorescent bead as a detector.
Higher sensitivity than the existing RDTs could be provided through advanced fluorescent detection with an UV
LED energy source.
Intented Use

This fluorescence immunoassay device that can perform qualitative and quantitative analysis on infections, respiratory diseases and chronic diseases supports convenient user interface and LIS/HIS connectivity.
Advantage

  • Fluorescent immunoassay system 24 tests at once
  • Top class performance with fluorescent technology
  • Ready-to-use reagents
  • Random Access
  • Automatic test device discarding

  • Specification
    • INPUT 

      AC 100~240V, 50/60Hz

    • Display 

      10.1” Color TFT LCD (1024 X 600)

    • Display Control 

      Graphic User Interface

    • Power Consumption 

      Up to 84W

    • Number of Memories 

      5,000 (Run Test)

    • Real Time Clock 

      Including RTC Backup Battery

    • LIS/HIS 

      HL7 PCD – 01 Profile Support

    • Dimension 

      510 X 566 X 297 mm

    • Inserts 

      User manual

    • Bar Code Scanner (Option) 

      USB Barcode Scanner

    • Weight 

      20 kg

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Ichroma T3 Test
  • Ichroma T3 Test
  • Ichroma T3 Test
  • Ichroma T3 Test
  • Ichroma T3 Test

Ichroma T3 Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
SamplesHuman serum/plasma/ control
Specimen volume75 Microliter
stored at4 - 30 DegreeC
Cat NoCFPC-44
T3

Assessing to diagnosis & to monitor thyroid diseases(T3)

This test assesses the level of T3 in the blood to diagnose thyroid dysfunction, help to receive appropriate treatment, and help to confirm the treatment effect through periodic measurement.

INTENDED USE :

  ichroma™ T3 is a fluorescence Immunoassay (FIA) for the

quantitative determination of triiodothyronine (total T3) in

human serum/plasma. It is useful as an aid in management

and monitoring of determination of thyroid disorders.

For in vitro diagnostic use only.

PRINCIPLE : 
  The test uses a competitive immunodetection method.

In this method, the analyte in the sample binds to the

fluorescence labeled (FL) detection antibody in detection

buffer, to form the complex as sample mixture. This complex

is loaded to migrate onto the nitrocellulose matrix, where

the covalent couple of T3 and bovine serum albumin (BSA) is immobilized and interferes with the binding of analyte and

fluorescence labeled (FL) antibody. If more analytes exist in

the sample, less detection antibodies are accumulated,

resulting in less fluorescence signal.

MATERIALS SUPPLIED :

   REF CFPC-44

Components of ichroma™ T3

  Cartridge Box:

- Cartridge 25

- Detector tube 25

- Detector diluent 2

- ID chip 1

- Instruction for Use 1

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Ichroma T4 Test
  • Ichroma T4 Test
  • Ichroma T4 Test
  • Ichroma T4 Test
  • Ichroma T4 Test

Ichroma T4 Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
SpecimenHuman serum/plasma/ control
Specimen volume75 microliter
stored at4 - 30 DegreeC.
Cat NoCFPC-26
T4

Assessing to diagnosis & to monitor thyroid diseases(T4)

Thyroxine (T4) is a type of thyroid hormone. An abnormal amount of T4 may indicate thyroid disease. The T4 test measures total T4, including T4 bonded to protein and free T4. A T4 test will help determine what type of problem is affecting the thyroid.

INTENDED USE : 

 ichroma™ T4 is a fluorescence Immunoassay (FIA) for the quantitative determination of thyroxine (T4) in human serum/plasma. It is useful as an aid in management and monitoring of thyroid disorder.

For in vitro diagnostic use only.

PRINCIPLE :

   The test uses a competitive immunodetection method.

In this method, the target material in the sample binds to the fluorescence (FL)-labeled detection antibody in detector, to form the complex as sample mixture. This complex is loaded to migrate onto the nitrocellulose matrix, where the covalent couple of T4 and bovine serum albumin (BSA) is immobilized on a test strip, and interferes with the binding of target material and FL-labeled antibody. If the more target material exists in blood, the less detection antibody is accumulated, resulting in the less fluorescence signal.

MATERIALS SUPPLIED : 
 
 REF CFPC-26

Components of ichroma™ T4

??? Cartridge Box:

- Cartridges 25

- ID Chip 1

- Insert 1

- Detector tube (Granule) 25

- Detector diluent (5.5 mL) 1  

 

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ichroma TSH Test
  • ichroma TSH Test
  • ichroma TSH Test
  • ichroma TSH Test
  • ichroma TSH Test

ichroma TSH Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
Sampleshuman serum/plasma
Specimen volume150 Microliter
stored at4 - 30 DegreeC.
Cat. NoCFPC-22
Thyroid Stimulating Hormone (TSH)

Diagnosing thyroid dysfunction

One needs an adequate level of thyroid hormone. The excessive or insufficient level would cause various abnormalities in human physiology. The TSH test can deliver the required answer about the hormone level in 12 minutes with fingertip blood (US FDA 510k; AFIAS TSH).

INTENDED USE :

  ichroma™ NT-proBNP is a fluorescence Immunoassay (FIA) for the quantitative determination of NT-proBNP in human whole blood/serum/plasma. It is useful as an aid in the diagnosis of persons suspected of having congestive heart failure.

For in vitro diagnostic use only.

PRINCIPLE :
   The test uses a sandwich immunodetection method; the detector antibodies in buffer bind to antigens in the sample, forming antigen-antibody complexes, and migrate onto the nitrocellulose matrix to be captured by the other immobilized-antibodies on test strip.

More antigens in the sample will form more antigen-antibody complexes which lead to stronger fluorescence signal by detector antibodies, which is processed by instrument for ichroma™ tests to show NT-proBNP concentration in the sample.

MATERIALS SUPPLIED : 

  REF CFPC-77

Components of ichroma™ NT-proBNP

  Cartridge Box:

- Cartridge 25

- ID Chip 1

- Instruction for Use 1

  Buffer Box

  For ichroma™ II

- Detector tube 25

- Detector diluent 1

  For ichroma™-50

- Detector tube 25

- Detector diluent 1

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ichroma Beta-HCG Test
  • ichroma Beta-HCG Test
  • ichroma Beta-HCG Test
  • ichroma Beta-HCG Test
  • ichroma Beta-HCG Test

ichroma Beta-HCG Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
Sampleshuman whole blood/serum /plasma
Specimen volumehuman whole blood/serum/ plasma
stored at4-30 C
Cat. No.CFPC-66
Human Chorionic Gonadotropin (β-hCG)

Distinguish pregnancy and abnormal pregnancy

The β-hCG test can be used to confirm pregnancy, the age of the fetus, abnormal pregnancy (ectopic pregnancy), potential miscarriage, and down syndrome.

INTENDED USE :

  ichroma™ β-HCG Plus is a fluorescence Immunoassay (FIA) for the

quantitative determination of β-HCG in human whole blood/serum

/plasma. It is useful as an aid in management and monitoring of beta

human chorionic gonadotropin (β-hCG) level in human

For in vitro diagnostic use only.

PRINCIPLE : 

  The test uses a sandwich immunodetection method; Dried

antibodies in the detector tube, once diluted with the diluent, bind

with antigens in the sample to form antigen-antibody complexes.

These complexes then migrate through the nitrocellulose matrix and

are captured by another sets of immobilized antibodies on the test line.

The more antigens in the sample, the more antigen-antibody

complexes, which leads to a stronger fluorescence signal. This signal

then is interpreted by the reader to display the β-HCG concentration in

the sample.

STORAGE AND STABILITY : 

The cartridge is stable for 20 months (while sealed in the original

aluminum foil pouch) if stored at 4-30 °C.

The detector, diluent and sample diluent are stable for 20 months

if stored at 2-8 °C.

After the cartridge pouch is opened, the test should be

 

performed immediately.

MATERIALS SUPPLIED :

REF CFPC-66

Components of ichroma™ β-HCG Plus

Cartridge Box:

- Cartridges 25

- ID Chip 1

- Instruction For Use 1

Buffer Box

ü For ichorma™ II

- Detectors (Capped with plastic lid) 25

 

- Diluent 1

For AFIAS-50

- Detectors (Sealed with aluminum foil) 25

- Diluent 1

Sample Diluent Box:

 

- Sample Diluent Tubes 25

 

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Standard F PCT FIA

Standard F PCT FIA

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Product Details:
BrandSD Biosensor
Size20 T
Test time15 minutes
SpecimenWhole blood/Serum/plasma
Specimen volume100 Microliter
Cat No10PCT20B
STANDARD F PCT FIA is a fluorescent immunoassay for the quantitative measurement of procalcitonin level in human serum, plasma, and whole blood. Procalcitonin helps assess the severity and prognosis of bacterial infections, and support early diagnosis of sepsis.

Advantage
  • Fluorescent technology- Optimized performance
  • Reagents can be stored at room temperature
  • No-coding via 2D barcode system

  • Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10PCT20BSTANDARD™ F PCT FIA2-30??? / 36-86???20T/kit
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Standard F Vitamin D FIA

Standard F Vitamin D FIA

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Product Details:
BrandSD Biosensor
Size20 T
Test time45 minutes
SpecimenSerum,Plasma
Specimen volume35 Microliter
Cat No10VIT10B
Intented Use

STANDARD F Vitamin D FIA is an in vitro diagnostic for the quantitative measurement
of total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum and plasma.

Ordering Information

Cat. No.ProductStorage temperatureTest/Kit
10VIT10BSTANDARD™ F Vitamin D FIA2-30??? / 36-86???20T/kit
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Standard F Dengue IgM/IgG FIA

Standard F Dengue IgM/IgG FIA

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Product Details:
BrandSD Biosensor
Size25 T
Test time5-15 mins
SpecimenWhole blood,Serum,Plasma
Specimen volume100 microliter
Cat No10DEN10D
Dengue NS1 Ag FIA

This product performs qualitative analysis on NS1 antigen of Dengue virus in serum, plasma and whole blood.

Advantage

  • Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance
  • Objective result - Eliminates the subjectivity of a visual result
  • Automatic strip recognition by reading the information stored in 2D barcode
  • Time saving by early detection

Ordering InformationStrep A Ag FIA
Cat. No.ProductStorage temperatureTest/Kit
10DEN10DSTANDARD™ F Dengue NS1 Ag FIA2-30??? / 36-86???25T/kit
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Standard F Dengue IgM/IgG FIA

Standard F Dengue IgM/IgG FIA

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Product Details:
BrandSD Biosensor
Size25 T
Test time15 mins
SpecimenWhole blood,Serum,Plasma
Specimen volume10 Microliter
Cat No10DEN20D
STANDARD F Dengue IgM/IgG FIA qualitatively analyzes Dengue virus specific IgM and IgG antibodies in serum, plasma and whole blood using fluorescent immunoassay. Screening test results can be obtained within 15 minutes with high sensitivity and specificity.

Advantage
  • Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance
  • Objective result - Eliminates the subjectivity of a visual result
  • Automatic strip recognition by reading the information stored in 2D barcode

Ordering Information
Cat. No.ProductStorage temperatureTest/Kit
10DEN20DSTANDARD™ F Dengue IgM/IgG FIA2-30??? / 36-86???25T/kit
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Standard F Covid-19 Ag FIA

Standard F Covid-19 Ag FIA

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Product Details:
BrandSD Biosensor
Size25 T
Test time30 minutes
Specimen volume4 drops
SpecimenNasopharyngeal,VTM specimen,sputum
Cat No10COV30D
STANDARD F COVID-19 Ag FIA is the fl uorescent immunoassay for the qualitative detection of specific nucleoprotein antigens to SARS-CoV-2 present in human nasopharynx. STANDARD F COVID-19 Ag FIA should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms with SARS-CoV-2 infection.

Advantage
  • Improved sensitivity through FIA method
  • Providing additional information through Cut-off Index value
  • Convenient data management via LIS/HIS connectivity
  • Ready-to-use & room temperature storage condition

Ordering Information
Cat. No.ProductStorage temperatureTest/Kit
10COV30DSTANDARD™ F COVID-19 Ag FIA2-30??? / 36-86???25T/kit
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Standard F iFOB FIA

Standard F iFOB FIA

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Product Details:
BrandSD Biosensor
Size50 T
Test time5 minutes
SpecimenFeces
Specimen volume3 drops
Cat No10IFO10C
STANDARD F iFOB FIA is a fluorescent immunoassay for the quantitative measurement of hemoglobin in fecal sample. This test is offered as a screening test for the early detection of bowel cancer in patients without symptoms.

Advantage
  • iFOB is a tumor marker for the diagnosis of bowel cancer
  • Automatic strip recognition by reading the information stored in 2D barcode
  • Reagents can be stored at room temperature

Ordering Information
Cat. No.ProductStorage temperatureTest/Kit
10IFO10CSTANDARD™ F iFOB FIA2-30??? / 36-86???50T/kit
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Standard F FT4

Standard F FT4

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Product Details:
BrandSD Biosensor
Size20 T
Test time15 minutes
SpecimenSerum
Specimen volume50 Microliter
Cat No10FT410B
STANDARD F fT4 is an immunoassay for the quantitative measurement of free thyroxin(fT4) level in human serum. This test is to help diagnose thyroid disorder; to monitor treatment of hypothyroidism and hyperthyroidism.

Advantage
  • Diagnosis of thyroid disorders
  • Monitoring treatment of hypothyroidism and hyperthyroidism

Ordering Information
Cat. No.ProductStorage temperatureTest/Kit
10FT410BSTANDARD™ F fT42-30??? / 36-86???20T/kit
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Standard F Chikungunya IgM/IgG FIA

Standard F Chikungunya IgM/IgG FIA

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Product Details:
BrandSD Biosensor
Size25 T
Test time15 mins
SpecimenWhole blood,Serum,Plasma
Specimen volume10 Microliter
Cat No10CHI10D
STANDARD F Chikungunya IgM/IgG FIA qualitatively analyzes Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood using fluorescent immunoassay. Screening test results can be obtained within 15 minutes with high sensitivity and specificity.

Advantage
  • Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance
  • Objective result - Eliminates the subjectivity of a visual result
  • Automatic strip recognition by reading the information stored in 2D barcode

  • Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10CHI10DSTANDARD™ F Chikungunya IgM/IgG FIA2-30??? / 36-86???25T/kit
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Ichroma AMH Test

Ichroma AMH Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
SamplesHuman serum/plasma/control
Specimen volume50 Microliter
stored at4 - 30 DegreeC
Cat NoCFPC-89
INTENDED USE :

ichroma™ AMH is a fluorescence Immunoassay (FIA) for the quantitative determination of AMH (Anti-müllerian hormone) in human serum/plasma. It is useful as an aid in management and monitoring of premature ovarian insufficiency, menopause and ovarian reserve.For in vitro diagnostic use only.


COMPONENTS : 

ichroma™ AMH consists of ‘cartridges’, ‘detectors’ and ‘diluent The cartridge contains the membrane called a test strip which has streptavidin at the test line and chicken IgY at the control line. All cartridges are individually sealed in an aluminum foil pouch containing a desiccant in a box The detector has 2 granules containing anti human AMH-fluorescence conjugate, anti-chicken IgY-fluorescence conjugate, anti-human AMH-biotin conjugate, bovine serum albumin (BSA) and sucrose as a stabilizer, MAB33 as a blocker in Tris-HCl buffer. All detectors are packed in a box The diluent contains bovine serum albumin and NaCl as a stabilizer, tween 20 and CA-630 as a surfactant and sodium azide as a preservative in phosphate buffered saline (PBS), and it is pre-dispensed in a vial. The diluent is packed in a box.


PRINCIPLE :

The test uses a sandwich immunodetection method; the detector antibodies in buffer bind to antigens in the sample, forming antigen-antibody complexes, and migrate onto nitrocellulose matrix to be captured by the other immobilized-antibody on test strip.More antigens in sample will form more antigen-antibody complexes which lead to stronger fluorescence signal by detector antibodies, which is processed by instrument for ichroma tests to show human AMH concentration in the sample.

INTERPRETATION OF TEST RESULT :

The instrument for ichroma™ tests calculates the test result automatically and displays AMH concentration of the test sample in terms of ng/mL.??? The working range: 0.02 – 15 ng/mL.
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ichroma FSH Test

ichroma FSH Test

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Product Details:
Number of Reactions(Preps)/Kit25 T
BrandBoditech Med Incorporated
Samplewhole blood (AFIAS), plasma, serum
Reaction Time15mins
Detection Rangeichroma(TM) (1 - 100 mIU/ml)
Cat NoCEPC-35
Follicle-stimulating Hormone (FSH)

Diagnosis of early menopause & ovarian degeneration and infertility

This test can help figure out the cause of infertility, problems with ovarian functions, menstrual abnormalities and congenital or acquired gonadotropin development disorder or infertility.

USO PREVISTO : 
      
ichroma™ FSH junto con el Lector ichroma™ es un inmunoensayo de fluorescencia que mide la concentración de Hormona Folículo Estimulante (FSH)en suero/plasma humano.


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ichroma LH Test

ichroma LH Test

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Product Details:
Number of Reactions(Preps)/Kit25 T
BrandBoditech Med Incorporated
Sample Volume75 Microliter
Samplehuman serum/plasma
Reaction Time15mins
Cat No13010
Luteinizing Hormone (LH)

Assessing and monitoring function of pituitary gland

This test helps evaluate pituitary function by quantifying luteinizing hormone in the blood, to diagnose pituitary gland disease, and to determine congenitally or acquired gonadotropin dysfunction.

INTENDED USE : 

    ichroma™ LH is a fluorescence Immunoassay (FIA) for the quantitative determination of Luteinizing hormone (LH) in human serum/plasma. It is useful as an aid in management and monitoring of determination of evaluating fertility issues, function of reproductive organs (ovaries or testicles), or detection of the ovulation.

For in vitro diagnostic use only.

PRINCIPLE:

   The test uses a sandwich immunodetection method; the detector antibody in buffer binds to antigen in sample, forming antigen-antibody complexes, and migrates onto nitrocellulose matrix to be captured by the other immobilized-antibody on test strip.

The more antigen in sample forms the more antigen-antibody complex and leads to stronger intensity of fluorescence signal on detector antibody, which is processed by instrument for ichroma™ tests to show LH concentration in sample.

MATERIALS SUPPLIED:
    REF 13010

Components of ichroma™ LH Cartridge Box:

- Cartridges 25

- ID Chip 1

- Instruction For Use 1 Box containing Detection Buffer Tubes

- Detection Buffer Tubes 25.


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Ichroma Ferritin Test

Ichroma Ferritin Test

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Product Details:
Number of Reactions(Preps)/Kit25 T
BrandBoditech Med Incorporated
Sample Volume30 Microliter
Samplehuman serum / plasma / control
Reaction Time10 mins
Cat NoCFPC-32
Ferritin

Monitoring deficiency/excess of iron & inflammation

Ferritin is a universal intracellular protein that stores iron and releases it in a controlled fashion. Too little ferritin can lead to anemia, while too much to liver disease, rheumatoid arthritis, other inflammatory conditions, or hyperthyroidism. The ferritin test measures the level of ferritin in the blood.

INTENDED USE :
     ichroma™ Ferritin is a fluorescence Immunoassay (FIA) for the quantitative determination of Ferritin in human serum/plasma. It is useful as an aid for quantifying human ferritin.

For in vitro diagnostic use only.

PRINCIPLE :

   The test uses a sandwich immunodetection method; the detector antibodies in buffer bind to antigen in the sample, forming antigen-antibody complexes, and migrates onto nitrocellulose matrix to be captured by the other immobilized-antibodies on test strip.

More antigens in the sample will form more antigen-antibody complexes which lead to stronger fluorescence signal by detector antibodies, which is processed by Instrument for ichroma™ tests to show ferritin concentration in sample.

 MATERIALS SUPPLIED :

    REF CFPC-32

Components of ichroma™ Ferritin

??? Cartridge Box:

- Cartridge 25

- Detector 25

- Detector Diluent 1

- ID Chip 1

- Instruction for Use 1

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ichroma PCT Test

ichroma PCT Test

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Product Details:
BrandBoditech Med Incorporated
Size25 T
Sampleshuman whole blood/serum/plasma
Specimen volume150 microliter
stored at4-30 DegreeC
Cat NoCFPC-23-1
PCT

Assessing initial risk of bacterial infection and fatal sepsis

Diagnosis of sepsis is routinely performed in intensive care units (ICU) of all hospitals. Early detection of sepsis is very important in determining appropriate treatment as it is known to improve patient survival through a various therapeutic strategy for sepsis. The ichroma™ & AFIAS PCT test helps detect bacterial sepsis and assess the risk of developing septic shock.

INTENDED USE : 

ichroma™ PCT is a fluorescence Immunoassay (FIA) for the quantitative determination of Procalcitonin (PCT) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of bacterial infection and sepsis.

For in vitro diagnostic use only.

PRINCIPLE :

The test uses a sandwich immunodetection method; the detector antibody in buffer binds to antigen in sample, forming antigen-antibody complexes, and migrates onto nitrocellulose matrix to be captured by the other immobilized-antibody on test strip.

 

The more antigen in sample forms the more antigen-antibody complex and leads to stronger intensity of fluorescence signal on detector antibody, which is processed by instrument for ichroma™ tests to show PCT concentration in sample.

STORAGE AND STABILITY:

The cartridge is stable for 20 months (while sealed in an aluminum foil pouch) if stored at 4-30 °C. The detection buffer dispensed in a tube is stable for 20 months if stored at 2-8 °C. After the cartridge pouch is opened, the test should be performed immediately.

MATERIALS SUPPLIED :

REF CFPC-23

Components of ichroma™ PCT Cartridge Box:

- Cartridges 10

- ID Chip 1

- Instruction For Use 1 Box containing Detection Buffer tubes

- Detection Buffer Tubes 10

 

 

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Ichroma CRP Test
  • Ichroma CRP Test
  • Ichroma CRP Test
  • Ichroma CRP Test
  • Ichroma CRP Test

Ichroma CRP Test

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Product Details:
Number of Reactions(Preps)/Kit25 T
BrandBoditech Med Incorporated
Sample Volume10 Microliter
SampleHuman whole blood/serum/ plasma/control
Reaction Time3 mins
Cat No :ichroma CRP-25
CRP

Assessing to diagnose infection and inflammation

This test can help with proper prescription and treatment by quickly and accurately measuring CRP with a finger-tip blood.

INTENDED USE :

  ichroma™ CRP is a fluorescence Immunoassay (FIA) for the quantitative determination of CRP in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis.

For in vitro diagnostic use only.

PRINCIPLE :

   The test uses a sandwich immunodetection method; the detector antibodies in buffer bind to antigens in the sample, forming antigen-antibody complexes, and migrate onto nitrocellulose matrix to be captured by the other immobilized-antibodies on test strip.

More antigens in the sample will form more antigen-antibody complexes which lead to stronger fluorescence signal by detector antibodies, which is processed by instrument for ichroma™ tests to show CRP concentration in the sample.

MATERIALS SUPPLIED : 

REF i-CHROMA CRP-25

Components of ichroma™ CRP

 Cartridge Box:

- Cartridge 25

- ID Chip 1

- Instruction for Use 1

- Sample Collector 25

 Box containing Detection Buffer

 

- Detection buffer 25

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Standrard F HbA1c

Standrard F HbA1c

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Product Details:
BrandSD Biosensor
Size20T
Test time5 minutes
SpecimenWhole blood
Specimen volume5 Micro liter
Cat No10A1C10B
STANDARD F HbA1c FIA performs quantitative analysis on glycosylated hemoglobin in whole blood samples using fluorescence immunochromatography. As STANDARD F Analyzer has been enhanced in its performance by using fluorescent substance, accurate quantitative test results can be obtained using with this product.
Advantage
  • Able to perform accurate quantitative analysis using fluorescent substance
  • Hb S, Hb F, Carbamylated Hemolgobin without interference phenomenon
  • Automatic strip recognition by reading the information stored in 2D barcode
  • IFCC / NGSP certified

Ordering Information
Cat. No.ProductStorage temperatureTest/Kit
10A1C10B STANDARD™ F HbA1c 2-30??? / 36-86??? 20T/kit

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Standard F RSV Ag FIA

Standard F RSV Ag FIA

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Product Details:
BrandSD Biosensor
Size25 T
Test time15 minutes (Strong positive can be read after 5 minutes.)
SpecimenNasopharyngeal swab / Nasopharyngeal aspirate / Nasopharyngeal wash / Transport media
Specimen volume4 drops
Cat No10RSVC10D
STANDARD F RSV Ag FIA performs qualitative analysis by detecting RSV antigens in the nasopharyngeal samples using fluorescence immunochromatography. This product’s performance is much higher than that of other products that use the existing Gold conjugate; through STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.

Advantage
  • Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance
  • Objective result - Eliminates the subjectivity of a visual result
  • Automatic strip recognition by reading the information stored in 2D barcode
  • Time saving by early detection

  • Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10RSVC10DSTANDARD™ F RSV Ag FIA2-30??? / 36-86???25T/kit
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Standard F S.Pneumoniae Ag FIA

Standard F S.Pneumoniae Ag FIA

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Product Details:
BrandSD biosensor
Size25 T
Test time10 minutes
SpecimenUrine, CSF
Specimen volume100 Microliter
Cat No10PN10D
STANDARD F S. pneumoniae Ag FIA test system (Analyzer + Test Device) finds S.pneumoniae antigen in urine if patients have pneumonia, and in cerebral spinal fluid sample if patients have meningitis.

Advantage
  • Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance
  • Objective result - Eliminates the subjectivity of a visual result
  • Automatic strip recognition by reading the information stored in 2D barcode
  • Time saving by early detection

  • Specification
    • Specimen 

      Urine, CSF

    • Test time 

      10 minutes

    • Specimen volume 

      100 µl

    • Sensitivity 

      100% (52/52)

    • Specificity 

      99.26% (135/136)

    • Storage temperature 

      2-30??? / 36-86???

  • Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10PN10DSTANDARD™ F S.pneumoniae Ag FIA2-30??? / 36-86???25T/kit
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    Standard F Strep A Ag FIA

    Standard F Strep A Ag FIA

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    Product Details:
    BrandSD Biosensor
    Size25 T
    Test time5 minutes
    SpecimenThroat swab
    Specimen volume100 Microliter
    Cat No10STR10D
    STANDARD F Strep A Ag FIA performs qualitative analysis by detecting Group A streptococcal antigens in samples using fluorescence immunochromatography. This product’s performance is much higher than that of other products that use the existing Gold conjugate; through STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.

    Advantage
    • Able to perform accurate quantitative analysis using fluorescent substance
    • Objective result - Eliminates the subjectivity of a visual result
    • Automatic strip recognition by reading the information stored in 2D barcode

    • Ordering Information
      Cat. No.ProductStorage temperatureTest/Kit
      10STR10DSTANDARD™ F Strep A Ag FIA2-30??? / 36-86???25T/kit

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    Standard F Legionella Ag FIA

    Standard F Legionella Ag FIA

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    Product Details:
    BrandSD Biosensor
    Test time15 minutes
    Size25 T
    Specimen volume100 Microliter
    SpecimenUrine
    Cat No10LEG10D
    STANDARD F Legionella Ag FIA test system (Analyzer + Test device) detects Legionella pneumophila serogroup 1, 3, 5, 6 and 8 antigens via urine sample. Without any further sample processing, STANDARD F Legionella Ag FIA performs highly sensitively, and the test is not affected by Rheumatoid factor.

    Advantage
    • Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance
    • Objective result - Eliminates the subjectivity of a visual result
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Time saving by early detection - in case of high titer samples, the analyzer automatically show the test results in 5 minutes.

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10LEG10D STANDARD™ F Legionella Ag FIA 2-30??? / 36-86??? 25T/kit

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    Strandard F U-Albumin FIA

    Strandard F U-Albumin FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time5 minutes
    SpecimenUrine
    Specimen volume3 MicroLiter
    Cat No10UAL10B
    STANDARD F U-Albumin FIA is a test for the quantitative measurement of microalbumin in human urine. This test is to aid to the prediction of diabetic nephropathy and cardiovascular diseases (CVD).

    Advantage
    • Able to perform accurate quantitative analysis using fluorescent substance
    • Reagents can be stored at room temperature
    • Automatic strip recognition by reading the information stored in 2D barcode

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10UAL10BSTANDARD™ F U-Albumin FIA2-30??? / 36-86???20T/kit
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    Standard F HS-CRP FIA

    Standard F HS-CRP FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time3 minutes
    SpecimenWhole blood,Serum,Plasma
    Specimen volume5 Microliter
    Cat No10HSC10B
    STANDARD F hs-CRP FIA performs quantitative measurement of high-sensitivity C-Reactive Protein (hs-CRP) in serum, plasma and whole blood samples using fluorescence immunochromatography. Through the STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.

    Advantage
    • hs-CRP is a cardiac marker for the diagnosis of cardiovascular inflammation and infection
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature
    • Serum, Plasma and Whole blood specimens available

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10HSC10BSTANDARD™ F hs-CRP2-30??? / 36-86???20T/kit
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    Standard F D-Dimer FIA

    Standard F D-Dimer FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time7 minutes
    SpecimenWhole blood(Sodium citrate),Plasma(Sodium citrate)
    Specimen volume10 Microliter
    Cat No10DDI10B
    STANDARD F D-dimer FIA performs quantitative measurement of D-dimer level in plasma and whole blood samples using fluorescence immunochromatography. Through the STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.

    Advantage
    • D-dimer is a cardiac marker for the diagnosis of thrombosis pulmonary embolism
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature
    • Plasma and Whole blood specimens available
    • Ordering Information
      Cat. No.ProductStorage temperatureTest/Kit
      10DDI10BSTANDARD™ F D-dimer FIA2-30??? / 36-86???20T/kit
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    Standard F NT-ProBNP FIA

    Standard F NT-ProBNP FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time15 minutes
    SpecimenWhole blood(EDTA),Serum
    Specimen volume100 Microliter
    Cat No10NTP10B
    STANDARD F NT-proBNP FIA is a quantitative test for the determination of the N-terminal pro brain-type natriuretic peptide (NT-proBNP) level in human serum and whole blood(EDTA).

    Advantage
    • Early diagnosis of acute heart failure
    • Risk stratification of heart failure
    • Useful tool to guide referral of chronic heart failure
    • Significant cost savings due to shorter stays in the ED

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10NTP10BSTANDARD™F NT-proBNP FIA2-30??? / 36-86???20T/kit
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    Standard F B-hCG FIA

    Standard F B-hCG FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time10 mins (Serum),15 mins (Whole blood)
    SpecimenWhole blood,Serum
    Specimen volume50 Microliter
    Cat No10BHC10B
    STANDARD F β-hCG FIA is a fluorescent immunoassay for the quantitative measurement of β-hCG level in human serum and whole blood. This test is performed to help diagnose pregnancy if a women is to undergo a medical treatment, be placed on certain drugs, or have other testing, such as x-rays, that might harm the developing baby.

    Advantage
    • β-hCG is a hormone that can diagnose early pregnancy
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature
    • Serum and Whole blood samples available

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10BHC10BSTANDARD™ F B-hCG FIA2-30??? / 36-86???20T/kit
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    Standard F LH FIA

    Standard F LH FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time15 minutes
    SpecimenWhole blood,Serum,Plasma
    Specimen volume20 Microliter
    Cat No10LH10B
    STANDARD F LH FIA is a fluorescent immunoassay for the quantitative measurement of LH level in human serum, plasma and whole blood. This test is performed to help evaluate fertility issues, function of reproductive organs (ovaries or testicles), or to detect the ovulation.

    Advantage
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature
    • Whole blood, serum and plasma specimens available

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10LH10BSTANDARD™ F LH FIA2-30??? / 36-86???20T/kit
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    Standard F TSH FIA

    Standard F TSH FIA

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time15 minutes
    SpecimenSerum
    Specimen volume100 Microliter
    Cat No10TSH10B
    STANDARD F TSH FIA is a fluorescent immunoassay for the quantitative measurement of Thyroid Stimulating Hormone level in human serum. This test is to help diagnose thyroid disorder; to monitor treatment of hypothyroidism and hyperthyroidism.

    Advantage
    • TSH is a hormone that can diagnose hypothyroidism and hyperthyroidism
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature

    • Ordering Information
      Cat. No.ProductStorage temperatureTest/Kit
      10TSH10BSTANDARD™ F TSH FIA2-30??? / 36-86???20T/kit
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    Standard F T4

    Standard F T4

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time15 minutes
    SpecimenSerum
    Specimen volume50 Microliter
    Cat No10T410B
    STANDARD F T4 is a quantitative test for the determination of the thyroxin (T4) in human serum.

    Advantage
    • Diagnosis of thyroid disorders
    • Monitoring treatment of hypothyroidism and hyperthyroidism

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10T410BSTANDARD™ F T42-30??? / 36-86???20T/kit
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    Standard F CRP

    Standard F CRP

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    Product Details:
    BrandSD Biosensor
    Size20 T
    Test time3 minutes
    SpecimenWhole blood,Serum,Plasma
    Specimen volume5 Microliter
    Cat No10CRP10B
    STANDARD F CRP is an immunoassay for the quantitative measurement of C-reactive protein level in human serum, plasma and whole blood. CRP helps access the severity and prognosis of inflammation and infection.

    Advantage
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Serum, Plasma and Whole blood samples available

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10CRP10BSTANDARD™ F CRP2-30??? / 36-86???20T/kit
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    Standard F CK-MB FIA

    Standard F CK-MB FIA

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    Product Details:
    BrandSD Biosensor
    Size20T
    Test time10 minutes
    SpecimenWhole blood(EDTA),Serum
    Specimen volume100 MicroLiter
    Cat No10CKM10B
    STANDARD F CK-MB FIA performs quantitative measurement of Creatine Kinase MB (CK-MB) level in plasma and whole blood samples using fluorescence immunochromatography. Through the STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.

    Advantage
    • CK-MB is a cardiac marker for the diagnosis of myocardial infarction
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature
    • Plasma and Whole blood samples available

    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10CKM10BSTANDARD™ F CK-MB FIA2-30??? / 36-86???20T/kit
    10CKBC10STANDARD™ F CK-MB Control2-30??? / 36-86???Lv1 x 10 / Lv2 x 10
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    Standard F TnI FIA

    Standard F TnI FIA

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    Product Details:
    Size20 T
    Differ(%)Within 15% (Serum) / Within 20% (Whole blood)
    Storage temperature2-30 C / 36-86 F
    Cat No10TNI10B
    STANDARD F TnI FIA performs quantitative measurement of Troponin I (TnI) level in plasma and whole blood specimens using fluorescence immunochromatography. Through the STANDARD F Analyzer, test results with high sensitivity and specificity can be obtained.

    Advantage
    • TnI is a cardiac marker for the diagnosis of myocardial infarction
    • Automatic strip recognition by reading the information stored in 2D barcode
    • Reagents can be stored at room temperature
    • Plasma and Whole blood specimens available
    Ordering Information
    Cat. No.ProductStorage temperatureTest/Kit
    10TNI10BSTANDARD™ F TnI FIA2-30℃ / 36-86℉20T/kit

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