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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

One Step SARS-nCoV2 (COVID-19) IgG/IgM test

Manufactured by Hangzhou Testsea Biotechnology Co. Ltd., China - www.testsealabs.com/ 

Device identification number
676
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Cassette
Target type
Antibody
Specimen
Whole blood
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
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