COVID-19 Ag Test - India CDSCO Medical Device Registration

COVID-19 Ag Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000095_f7985e36bfdeef05bcc83952e913f945_bffbe79495ade2cbe2890eb1e2d847a3. This device is marketed under the brand name Sensit Rapid. The license holder is Ubio Biotechnology Systems Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

COVID-19 Ag Test

UID: MFG/IVD/2020/000095_f7985e36bfdeef05bcc83952e913f945_bffbe79495ade2cbe2890eb1e2d847a3

Brand Name

Sensit Rapid

License Holder

Ubio Biotechnology Systems Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

COVID-19 Ag Test kit is an IVD medical device intended for the qualitative detection of SARS-COV2 antigen in human nasopharyngeal or throat specimen, which indicates COVID-19 infection