HCV IgG ELISA Kit - India CDSCO Medical Device Registration

HCV IgG ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_d2973b2d3c60aea1cb51721dde2b2d85_70dec1238a6dc89dce009751b77705fa. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

HCV IgG ELISA Kit

UID: MFG/IVD/2020/000038_d2973b2d3c60aea1cb51721dde2b2d85_70dec1238a6dc89dce009751b77705fa

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 HCV IgG ELISA Kit is a solid phase enzyme linked immunoabsorbent assay for the qualitative detection of IgG 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 HCV IgG ELISA Kit must be confirmed with alternative testing method(TRUSTwell) and clinical findings

Class D

Brand: TRUSTline

Class D