Malaria Ag ELISA Kit - India CDSCO Medical Device Registration

Malaria Ag ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_93e80588e575f3c8b57b9aa76b92181e_4a47a456c53c51fdd553b9ae123a090b. 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

Malaria Ag ELISA Kit

UID: MFG/IVD/2020/000038_93e80588e575f3c8b57b9aa76b92181e_4a47a456c53c51fdd553b9ae123a090b

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 Malaria Ag ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of malarial antigen (TRUSTwell) in human whole blood. It is intended for professional use only as an aid in the diagnosis of infection with Malaria parasites

Class D

Brand: TRUSTline

Class D