HIV Ag-Ab ELISA Kit - India CDSCO Medical Device Registration

HIV Ag-Ab ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_a06b1927c12397eef48eb4bb09b30281_7de82e8e54dc9c202b842d84513dfbfa. 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

HIV Ag-Ab ELISA Kit

UID: MFG/IVD/2020/000038_a06b1927c12397eef48eb4bb09b30281_7de82e8e54dc9c202b842d84513dfbfa

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 HIV Ag-Ab ELISA Kit is a solid phase enzyme linked immunoabsorbent assay for the qualitative detection of HIV-1 P24 antigen, anti-HIV-1 including subtype O and anti-HIV-2 antibodies (TRUSTwell) in human serum or plasma. It is intended for professional use only as an aid in the early identification of infection with HIV-1 and HIV-2 viruses. Any reactive specimen with the HIV Ag-Ab ELISA Kit must be confirmed with alternative testing method(TRUSTwell) and clinical findings

Class D

HCV Total Ab ELISA Kit V 4.0

Brand: TRUSTwell

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D