Hepatitis C Virus Test Kit - India CDSCO Medical Device Registration

Hepatitis C Virus Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000082_64337b908a177c60384b13dfa411a3f4_7071e126a8aa6035dfafc350e01e695b. This device is marketed under the brand name HCV. The license holder is Recombigen Laboratories Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Hepatitis C Virus Test Kit

UID: MFG/IVD/2023/000082_64337b908a177c60384b13dfa411a3f4_7071e126a8aa6035dfafc350e01e695b

Brand Name

HCV

License Holder

Recombigen Laboratories Pvt Ltd

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The HCV (HCV) Rapid Test (HCV) is a sandwich lateral ow chromatographic immunoassay for the qualitative detection of antibodies (HCV) to HCV (HCV) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HCV. Any reactive specimen with the HCV (HCV) Rapid Test Cassette must be conrmed with alternative testing method(HCV) and clinical findings