Malaria Pf/Pv Ag Rapid Test - India CDSCO Medical Device Registration

Malaria Pf/Pv Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000095_15b72584d6c8f9507e84bee40f25f56f_6014b184943152820fd0dbb48edf936f. This device is marketed under the brand name Sensit Rapid. The license holder is Ubio Biotechnology Systems Private Limited, and it is classified as Device Class Class C. 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 C

Malaria Pf/Pv Ag Rapid Test

UID: MFG/IVD/2020/000095_15b72584d6c8f9507e84bee40f25f56f_6014b184943152820fd0dbb48edf936f

Brand Name

Sensit Rapid

License Holder

Ubio Biotechnology Systems Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Sensit Malaria Pf/Pv Antigen Rapid Test Kit is a qualitative immunochromatographic assay for the simultaneous detection and differentiation of P. falciparum and P. vivax, in human blood. The Sensit Malaria P.f/Pv Antigen test is only intended for initial screening and reactive samples should be confirmed by a supplemental assay