Malaria Pv/Pf 2.0 Antigen Rapid Card Test - India CDSCO Medical Device Registration

Malaria Pv/Pf 2.0 Antigen Rapid Card Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000133_bbbd7aff5c0940cd3cf8046d5a8646df_60b5fe862479d45a2bf3416bfbc6b6ab. This device is marketed under the brand name Lateral Flow. The license holder is M/s Avantor Performance Materials India Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Malaria Pv/Pf 2.0 Antigen Rapid Card Test

UID: MFG/IVD/2023/000133_bbbd7aff5c0940cd3cf8046d5a8646df_60b5fe862479d45a2bf3416bfbc6b6ab

Brand Name

Lateral Flow

License Holder

M/s Avantor Performance Materials India Private Limited

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Malaria Pv/Pf 2.0 Antigen Rapid card test is a quick Immuno-chromatographic qualitative,sensitive and specific test for the disntinct dianostic of Pv specific LDH and Pf specific HRP2. allowing it to detect Pv and Pf distinctly. This test is only a preliminary screening test for malaria differential diagonis and for in-vitro diagnostic use only