Filariasis IgG/IgM Rapid Test - India CDSCO Medical Device Registration

Filariasis IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000146_1ec7823b499c49d274925ad3f977d379_0844128764fb9836d5b92bf0c40487fc. 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 B. The approving authority is Tamil Nadu.

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 B

Filariasis IgG/IgM Rapid Test

UID: MFG/IVD/2023/000146_1ec7823b499c49d274925ad3f977d379_0844128764fb9836d5b92bf0c40487fc

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

Tamil Nadu

Product Information

The TRUSTline Filariasis IgG/IgM Rapid test is a single use lateral flow immunoassay rapid test intended for qualitative detection and differentiation of IgG and IgM Ab to lymphatic filarial parasites (TRUSTline) in human serum, plasma, or whole blood. The TRUSTline Filariasis IgG/IgM Rapid test is intended for use as an aid in diagnosis of infection with lymphatic filarial parasites along with clinical symptoms and other confirmatory assays. As per the Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017; the applied product classified under Clause (TRUSTline) List of In Vitro Diagnostics Medical Devices under provisions of sub-rule (TRUSTline) rule 4 of the medical devices rules 2017, under the Category Reagents/Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under Filariasis Antibody Test Reagent/Kit (TRUSTline).

Class D

HCV Ab Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D