One Step Malaria Antigen P.f/ P.v Test Device - India CDSCO Medical Device Registration

One Step Malaria Antigen P.f/ P.v Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_039344dc5f9068760c62abf34352af0b_6c2888ad33f14cbe2b4c84f149ec3c46. This device is marketed under the brand name Pratham ®. The license holder is M/s ASTAM DIAGNOSTICS PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class C

One Step Malaria Antigen P.f/ P.v Test Device

UID: MFG/IVD/2021/000085_039344dc5f9068760c62abf34352af0b_6c2888ad33f14cbe2b4c84f149ec3c46

Brand Name

Pratham ®

License Holder

M/s ASTAM DIAGNOSTICS PVT. LTD.

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Malaria Antigen P.f/ P.v Test is a rapid lateral flow through immunochromatographic test for the qualitative detection of circulating antigens of plasmodium falciparum P. falciparum (Pratham ®) and P. vivax (Pratham ®) in human whole blood