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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019- nCoV Antigen Rapid Test

Manufactured by Ustar Biotechnologies (Hangzhou) Ltd., China - en.bioustar.com 

Device identification number
1873
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Oropharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The 2019-nCoV Antigen Rapid Test is intended for qualitative in-vitro diagnosis of the nucleoprotein antigen of novel coronavirus (2019-nCoV) in the human saliva, oropharyngeal and nasopharyngeal swab samples.
Assay Type
Immuno-Antigen
Method
Immunoassay

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