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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AFIAS COVID-19 Ab, IgM/IgG

Manufactured by Boditech Med Inc., South Korea - https://www.boditech.co.kr/en 

Device identification number
836
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Fingertip
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
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