HIV 1/2 Ab Rapid Test - India CDSCO Medical Device Registration

HIV 1/2 Ab Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_c0cce8430f6ab14a52e1625e8501dfbb_cc1181391dacb438a70d071904719f5e. 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.

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 1/2 Ab Rapid Test

UID: MFG/IVD/2020/000046_c0cce8430f6ab14a52e1625e8501dfbb_cc1181391dacb438a70d071904719f5e

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 HIV 1/2 Ab Rapid Test is intended for use by healthcare professionals and a rapid, qualitative, screening lateral flow chromatographic immunoassay for the simultaneous detection & differentiation of HIV-1 & HIV-2 antibodies (TRUSTline) in human serum, plasma or whole blood. The test kit is not automated and does not require any additional instrument. Any reactive specimen with the TRUSTline HIV 1/2 Ab Rapid Test must be confirmed with alternative testing method(TRUSTline) such as ELISA, Western Blot assay or PCR and clinical findings

Class D

Malaria Pf/Pan Ag Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D