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Rapid Test for PAN/Pf Malaria Antigen Device - India CDSCO Medical Device Registration

Rapid Test for PAN/Pf Malaria Antigen Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000130_95c278dd5c66cd10c18d0e6ed75a12c2_f3d8c86614b2b01ea30bbdf03c56997e. 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 PAN/Pf Malaria Antigen Device
UID: MFG/IVD/2020/000130_95c278dd5c66cd10c18d0e6ed75a12c2_f3d8c86614b2b01ea30bbdf03c56997e

Brand Name

Paracheck Pf Device

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

This test 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) and Pan malaria specific pLDH

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