Pure Global

Malaria P.f/PAN 3 Line Antigen Test - India CDSCO Medical Device Registration

Malaria P.f/PAN 3 Line Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000013_ffca1aac10ded7908c0658e6f19b9ed9_7cb8b7b81457542398930a442d55e7e1. This device is marketed under the brand name Pv, Pm, Po. The license holder is Bhat Bio-Tech India Private Limited, and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.

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 D
Malaria P.f/PAN 3 Line Antigen Test
UID: MFG/IVD/2020/000013_ffca1aac10ded7908c0658e6f19b9ed9_7cb8b7b81457542398930a442d55e7e1

Brand Name

Pv, Pm, Po

Device Class

Class D

Approving Authority

Sub Zonal Bangalore

Product Information

MALARIA P.f/P.v. 3 Line Test antigen is an immunochromatographic based assay for the qualitative detection of Plasmodium lactate dehydrogenase (Pv, Pm, Po) specific to Malaria P.v P.m P.o. and HRP II antigens specific to P.f. in human whole blood

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing