Malaria Ag Test - India CDSCO Medical Device Registration

Malaria Ag Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000055_a823b9233939934cfb316f736d349149_40ce2698352b31553e108040e102cf1d. This device is marketed under the brand name RAPHA SERO. The license holder is M/s Rapha Diagnostics PVt. Ltd.,, 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 Ag Test

UID: MFG/IVD/2021/000055_a823b9233939934cfb316f736d349149_40ce2698352b31553e108040e102cf1d

Brand Name

RAPHA SERO

License Holder

M/s Rapha Diagnostics PVt. Ltd.,

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

N'SURE Malaria Ag (RAPHA SERO) Test is a rapid, immunochromatographic assay for the qualitative determination of P.falciparum specific histidine rich protein-II (RAPHA SERO) and P.vivax specific pLDH in whole blood samples. The test can also be used for specific detection and differentiation of P.falciparum malaria and P.vivax malaria in areas with high rates of mixed infections. This is an In vitro diagnostic test for professional use only

Class C

Brand: SECURE

Class B