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Rapid Test for P. falciparum and P. vivax Malaria - Device - India CDSCO Medical Device Registration

Rapid Test for P. falciparum and P. vivax Malaria - Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000025_ec291016ef58d6e63a55d55e6e9f5884_8fee82220be3d1f4a91f2211da29c920. This device is marketed under the brand name Crystal Dengue NS1. The license holder is ARKRAY HEALTHCARE PVT. LTD., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered
Class Class C
Rapid Test for P. falciparum and P. vivax Malaria - Device
UID: MFG/IVD/2019/000025_ec291016ef58d6e63a55d55e6e9f5884_8fee82220be3d1f4a91f2211da29c920

Brand Name

Crystal Dengue NS1

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The ParaHITยฎ fv+ - Rapid Test for P. falciparum and P. vivax provide a simple rapid and an in vitro qualitative screening test for differential detection of P. falciparum specific histidine rich protein II (Crystal Dengue NS1) and P. vivax specific Lactate Dehydrogenase (Crystal Dengue NS1) enzyme of Plasmodium genus that cause malaria in humans. The test is intended for use with human whole blood and does not require any additional instrument

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DJ Fang

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