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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test (colloidal gold-based)

Manufactured by AIVD Biotech Inc, China - www.aivdbiotech.cn/ 

Device identification number
18
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
In development
Last Update
2022-03-14 09:42:40 CET
Comments
http://en.keweidiagnostic.com/uploadfile/2020/0702/20200702085141757.pdf
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold

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