SD Biosensor Archives

CKMB

STANDARD F CK-MB FIA is a fluorescent immunoassay for the quantitative measurement of Creatine Kinase Isoenzyme-MB level in human serum and whole blood. This test is to screen and monitor the Acute Myocardial Infarction (AMI).

Specimen	Serum, Whole blood
Sample volume	100µl
Range	1~200ng/mL
Time	15mins
Temperature	2-30? / 36-86?
Shelf life	18 months

Requires Standard F Analyzer system

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D-Dimer

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

Specimen	Plasma, Whole blood
Sample volume	10µl
Measurement Range	25-5,000mg/mL
Time	7mins
Temperature	2-30? / 36-86?
Shelf life	18 months

Requires Standard F Analyzer system

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hs-CRP

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.

Specimen	Serum, Plasma, Whole blood
Sample volume	5µl
Range	0.1-15.0mg/L
Time	3mins
Temperature	2-30? / 36-86?
Shelf life	18 months

Requires Standard F Analyzer system

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NT-proBNP

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).

Specimen	Whole blood (EDTA), Serum
Sample volume	100µl
Measurement Range	0 ~ 25,000pg/mL
Time	15mins
Temperature	2-30? / 36-86?
Shelf life	18 months

Requires Standard F Analyzer system

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STANDARD F COVID-19 Ag FIA

KOREA MFDS Approved

STANDARD F COVID-19 Ag FIA is the fluorescent immunoassay to detect SARS-CoV-2 infection in human nasopharyngeal swab specimen, identifying existence of SARS-CoV-2 viral nucleoprotein antigens.

Fast results as soon as 15 mins
Higher sensitivity than rapid test
Easy to use
Fluorescent Immunoassay (Europium)

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STANDARD F COVID-19 IgM/IgG Combo FIA

This kit is the fluorescent immunoassay to detect the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid. KOREA MFDS Approved

STANDARD F COVID-19 IgM/IgG Combo FIA is the fluorescent immunoassay to detect the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

Fast results as soon as 15 mins
Higher sensitivity than rapid test
Easy to use
Fluorescent Immunoassay (Europium)

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Standard F SD Biosensor

STANDARD F COVID-19 Ag FIA is the fluorescent 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.

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STANDARD F200 Analyzer

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.

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STANDARD F2400 Analyzer

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

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STANDARD-M-Flu-SARS-CoV-2-Real-Time-Detection-kit

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STANDARD M Flu/SARS-CoV-2 Real-Time Detection kit

This kit is the fluorescent immunoassay to detect the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

The STANDARD M Flu/SARS-CoV-2 Real-Time Detection Kit is a real-time reverse transcription PCR assay for the simultaneous detection of Flu A, Flu B and SARS-CoV-2 nucleic acids in human nasopharyngeal swab, oropharyngeal swab, and sputum specimens.

Single tube reaction for detection of SARS-CoV-2, Flu A and Flu B
One-step Real-Time RT-PCR
Provide all reagents required for RT-PCR
Multiple SARS-CoV-2 target genes: ORF1ab and E gene
Conserved Flu target region: Flu A (Matrix gene), Flu B (NS1 gene)
Internal control: RNA process control (from NA extraction)

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STANDARD M nCoV Real-Time Detection kit

FDA EUA Approved

KOREA MFDS Approved

STANDARD M nCoV Real-Time Detection kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples.

One tube reaction for identification and detection of 2019-nCoV
One-step Real-Time RT-PCR
Provide all reagents required for PCR
Designed according to “WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans”
nCoV primers/probes ORF1ab (RdRp) gene, E gene
Provide Internal controls

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STANDARD Q COVID-19 Ag

WHO EUL KOREA MFDS Approved TGA Approved

STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.

Fast results within 15~30 mins
Easy to use
Specimen : Nasopharyngeal swab
All necessary reagents provided & no equipment needed

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STANDARD Q COVID-19 IgM/IgG Combo

This kit is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

STANDARD Q COVID-19 IgM/IgG Combo Test Kit is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG to SARS-CoV-2 in humoral fluid.

Rapid testing for SARS-CoV-2 antibodies within 10~15 minutes
Specimen : Whole blood (20ul), serum , plasma (10ul)
Suitable for Point of Care Testing. No need for extra equipment

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STANDARD Q COVID-19 IgM/IgG Duo

This kit is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

STANDARD Q COVID-19 IgM/IgG Duo Test Kit is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG to SARS-CoV-2 in humoral fluid.

Rapid testing for SARS-CoV-2 antibodies within 10 minutes
Just 10ul of specimen : Whole blood, serum , plasma
Suitable for Point of Care Testing. No need for extra equipment

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STANDARD Q COVID-19 IgM/IgG Plus

This kit is a rapid chromatographic immunoassay for the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

KOREA MFDS Approved

STANDARD Q COVID-19 IgM/IgG Plus Test kit is a rapid chromatographic immunoassay for the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

Rapid testing for SARS-CoV-2 antibodies within 10-15 minutes
Specimen : Whole blood (20ul), serum, plasma (10ul)
Suitable for Point of Care Testing. No meed for extra equipment

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Standard Q SD Biosensor

Quick diagnosis STANDARD Q provides rapid diagnostic products with high sensitivity and specificity through quality control from raw material development to production.

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