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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay)

Manufactured by H&Z Life Science Co. Ltd - www.hzlifescience.com 

Device identification number
1172
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody, IgG, IgM
Specimen
Other, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-03-31 11:00:46
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes

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