Pure Global

Syphilis Ab Rapid Test - India CDSCO Medical Device Registration

Syphilis Ab Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000109_599b32e873699a913259abc373b9d3fd_0db781cb9fb581361462079957577061. This device is marketed under the brand name 3 Parameters. The license holder is Biotrol Laboratories Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is West Delhi Division.

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
Powered by Pure Global AI
CDSCO Registered
Class Class B
Syphilis Ab Rapid Test
UID: MFG/IVD/2021/000109_599b32e873699a913259abc373b9d3fd_0db781cb9fb581361462079957577061

Brand Name

3 Parameters

Device Class

Class B

Approving Authority

West Delhi Division

Product Information

The Syphilis Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (3 Parameters) in human serum or plasma. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with Tp

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing