Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 IgM Ab Rapid Test

Manufactured by Sure Bio-Tech (USA) Co. Ltd., United States - www.surebiotech.com/ 

Device identification number
391
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antibody, IgM
Targets
nucleocapsid protein
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Type of antigen
nucleocapsid 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