COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
Manufactured by Hangzhou Testsea Biotechnology Co. Ltd., China - www.testsealabs.com/
Device identification number
857
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
5 minutes
Detection Principle
Colloidal gold
Accuracy
94 %
Clinical Sensitivity
88 %
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