HCV Total Ab ELISA Kit V 4.0 - India CDSCO Medical Device Registration

HCV Total Ab ELISA Kit V 4.0 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_0e2e9d052b92b79f83ac0fa24eefb094_abca6610b827ca32768653d5df096ad5. This device is marketed under the brand name TRUSTwell. 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 Total Ab ELISA Kit V 4.0

UID: MFG/IVD/2020/000038_0e2e9d052b92b79f83ac0fa24eefb094_abca6610b827ca32768653d5df096ad5

Brand Name

TRUSTwell

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The CTK HCV Total Ab ELISA Kit V 4.0 is a solid-phase enzyme linked immunosorbent assay for the qualitative detection of antibodies (TRUSTwell) to Hepatitis C virus (TRUSTwell) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HCV. Any reactive specimen with the CTK HCV Total Ab ELISA Kit V 4.0 must be confirmed with alternative testing method(TRUSTwell) and clinical findings

Class D

Brand: TRUSTline

Class D