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Rapid Test for Malaria PAN/Pv/Pf (Paramax-3 ) - India CDSCO Medical Device Registration

Rapid Test for Malaria PAN/Pv/Pf (Paramax-3 ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000130_296b34d8edae6fe81c4349d12483b2b7_1b0479fa5f12f06f947ddf782131f9dc. This device is marketed under the brand name Paracheck Pf Device. The license holder is VIOLA DIAGNOSTIC SYSTEMS - A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED,, 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
Rapid Test for Malaria PAN/Pv/Pf (Paramax-3 )
UID: MFG/IVD/2020/000130_296b34d8edae6fe81c4349d12483b2b7_1b0479fa5f12f06f947ddf782131f9dc

Brand Name

Paracheck Pf Device

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Paramax-3 is a rapid, qualitative, two site sandwich immunoassay utilizing whole blood for the detection of P.falciparum specific histidine rich protein-2 (Paracheck Pf Device), P.vivax specific pLDH and Pan malaria specific pLDH. The test can be used for the specific detection of P.falciparum and P.vivax malaria, differentiation of other malarial species and for the follow up of antimalarial therapy

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