SARTS-CoV2 IgM/IgG antibody test
Manufactured by Shanghai B&C Biological Technology, China - www.beixi.com/
Device identification number
1015
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.medicalexpo.es/prod/shanghai-b-c-biological-technology-co-ltd/product-129056-952556.html
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Clinical Sensitivity
96.6 %
Clinical Specificity
93.8 %
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