COVID-19 In Vitro Diagnostic Devices and Test Methods Database
COVID-19 In Vitro Diagnostic Medical Device - detail
SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)
Manufactured by BIOHIT HealthCare (Hefei) Co. Ltd., China - www.biouhan.com
Device identification number
87
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Wash aspirate
Cross-reactivity (pathogens tested)
Anti-Nuclear Antibody, Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Influenza A, Influenza B, Respiratory Syncytial V (RSV)
The SARS-CoV-2 IgM/IgG antibody test kit is based on the immunochromatographic method. The SARS-CoV-2 IgM/IgG is detected by SARS-CoV-2 recombinant N protein.
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