# 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
    
 -	Optimized for field diagnostics with small size (Clinic, Laboratory)
    
 -	Recognize information stored in 2D barcode
    
 -	Internal quality control
    
 -	LIS/HIS connectivity

STANDARD F200 Analyser

STANDARD F200 Analyser is a fluorescence immunoassay device that can perform qualitative and quantitative analyses on infections, respiratory diseases and chronic diseases, and it supports convenient user interface and LIS/HIS connectivity.

# 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

STANDARD F2400 Analyser

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 product performs quantitative analysis on D-dimer in plasma and whole blood.
    
 # 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

STANDARD F D-dimer FIA

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 Analyser, test results with high sensitivity and specificity can be obtained.

# Intented Use

    
 This product performs quantitative analysis on luteinizing hormone (LH) level in serum, plasma and whole blood.
    
 # 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

STANDARD F LH FIA

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.

# Intented Use

    
 This product performs quantitative analysis on prostate-specific antigen (PSA) in serum, plasma and whole blood.
    
 # Advantage
    
 -	PSA is a tumor marker for the diagnosis of prostate cancer
    
 -	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

STANDARD F PSA FIA

STANDARD F PSA FIA performs quantitative measurement of prostate-specific antigen (PSA) level in serum, plasma and whole blood samples using fluorescence immunochromatography. Through the STANDARD F Analyser, test results with high sensitivity and specificity can be obtained.

# Intended Use

    
 This product performs quantitative analysis on glycated hemoglobin in the whole blood samples.

STANDARD F HbA1c

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.
    
 -	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

# Intented Use

    
 This product performs quantitative analysis on beta human Chorionic Gonadotropin (β-hCG) in serum and whole blood.
    
 # 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

STANDARD F β-hCG FIA

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.

# Intented Use

    
 This product performs quantitative analysis on CRP (C-Reactive Protein) in serum, plasma and whole blood.
    
 # Advantage
    
 -	Automatic strip recognition by reading the information stored in 2D barcode
    
 -	Serum, Plasma and Whole blood samples available

STANDARD F CRP

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.

# Intented Use

    
 
    
 # Advantage
    
 -	Total Antibody test (IgM and IgG)
    
 -	Superior sensitivity & specificity
    
 -	Suitable method for population antibody screening

STANDARD F COVID-19 IgM/IgG Combo FIA

STANDARD F COVID-19 IgM/IgG Combo FIA is the fl uorescent immunoassay for the qualitative detection of specific antibodies to SARS-CoV-2 present in human serum and whole blood. STANDARD F COVID-19 IgM/IgG Combo FIA should be used with the STANDARD F Analysers manufactured by SD BIOSENSOR. This test is for in vitro professional diagnostic use and intended as an aid to diagnosis of SARS-CoV-2 infection in convalescent phase of patient with clinical symptoms with SARS-CoV-2 infection.

# Intented Use

    
 STANDARD F H. pylori Ag FIA is a fluorescent immunoassay for the detection of H.pylori antigen in human fecal specimens.

Standard F H.Pylori FIA

# Intented Use

    
 This product performs qualitative analysis on hepatitis C virus-specific antibodies in serum, plasma and whole blood.

Standard F HCV Ab FIA

STANDARD F HCV Ab qualitatively analyzes antibodies specific to hepatitis C virus in serum, plasma and whole blood using Fluorescent Immunoassay (FIA). With a simple test method, the test result can be obtained within 5 minutes with its high sensitivity and specificity.
    
 -	Easy to use, Easy to read and interpret
    
 -	Room temperature storage

# Intented Use

    
 STANDARD F HBsAg FIA is a fl uorescent immunoassay for the qualitative detection of Hepatitis B surface antigen (HBsAg) present in whole blood, serum and plasma.

Standard F HbsAg FIA

# Intented Use

    
 This product performs qualitative analysis on hepatitis A virus IgM antibody in serum, plasma and whole blood.
    
 -	Easy to use, Easy to read and interpret
    
 -	Room temperature storage

Standard F HAV IgM FIA

STANDARD F HAV IgM qualitatively analyzes hepatitis A virus IgM antibody in serum, plasma and whole blood using Fluorescent Immunoassay (FIA). With a simple test method, the test result can be obtained within 15 minutes with its high sensitivity and specificity.

# Intented Use

    
 This product performs quantitative analysis on Troponin I (TnI) in plasma and whole blood

Standard F Tnl FIA

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.
    
 -	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

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