HCV Ab Rapid Test - India CDSCO Medical Device Registration

HCV Ab Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_846292141bd33b1108eef281fc3b4bda_2bb19dd9c232b5cb3014b9d0d7990292. 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 D. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class D

HCV Ab Rapid Test

UID: MFG/IVD/2020/000046_846292141bd33b1108eef281fc3b4bda_2bb19dd9c232b5cb3014b9d0d7990292

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The TRUSTline HCV Ab Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies (TRUSTline) in human serum or plasma. It is intended to be used by healthcare professionals as a screening test and as an aid in the diagnosis of infection with HCV. The test kit is not automated and does not require any additional instrument. Any reactive specimen with the TRUSTline HCV Ab Rapid Test must be confirmed with alternative testing method(TRUSTline) and clinical findings