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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SCoV-2 DetectTM IgM ELISA

Manufactured by Viracor Eurofins, United States - www.viracor-eurofins.com/clinical-diagnostics/ 

Device identification number
1624
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
ELISA
Analysis of cross reactivity
Anti-Influenza A/B, Anti-Hepatitis B, Anti-Hepatitis C, Anti-Nuclear Antibody, Rheumatoid Factor, Human Anti-Mouse Antibody, Anti-HIV, Anti-Respiratory Syncytial Virus, Normal Human sera
False positives
7.5 % (92.50% (111/120))
False negatives
1.05 % (98.95% (94/95))
Reproducibility
13.3 % (CI95: 13.3-24.3%)

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements