COVID-19 Ag Rapid Test - India CDSCO Medical Device Registration

COVID-19 Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_9c72700591e0bddb084d6fb85623b765_662fdc1de8d3d8492699d0a53982a511. This device is marketed under the brand name TRUSTline. The license holder is Athenese-Dx 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 Rapid Test

UID: MFG/IVD/2020/000046_9c72700591e0bddb084d6fb85623b765_662fdc1de8d3d8492699d0a53982a511

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The TRUSTline COVID-19 Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal (TRUSTline) swab specimens from individuals who are suspected of COVID-19. This test is an aid to early diagnosis of SARS-CoV-2 infection along with clinical symptoms and other confirmatory assays

Class D

HCV Ab Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D