Syphilis Ab Rapid Test - Dip Strip - India CDSCO Medical Device Registration

Syphilis Ab Rapid Test - Dip Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_ec54be2cb99119d6cbd4fb06cc11a9f2_b1b6e290de1f54d1e294a49ce65b8810. 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

Syphilis Ab Rapid Test - Dip Strip

UID: MFG/IVD/2020/000046_ec54be2cb99119d6cbd4fb06cc11a9f2_b1b6e290de1f54d1e294a49ce65b8810

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 Syphilis Ab Rapid Test - Dip Strip is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (TRUSTline) to Treponema pallidum (TRUSTline) in human serum or plasma. It is intended to be used by healthcare professionals as a screening test and as an aid in the diagnosis of infection with Tp. The test is not automated and does not require any additional instrument. Any reactive specimen with the TRUSTline Syphilis Ab Rapid Test must be confirmed with alternative testing method(TRUSTline) and clinical findings

Class D

Malaria Pf/Pan Ag Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D