Rapid Test for P. falciparum and P. vivax Malaria - Device
- UID
- MFG/IVD/2019/000025_ec291016ef58d6e63a55d55e6e9f5884_8fee82220be3d1f4a91f2211da29c920
- Device class
- Class C
- Brand name
- Crystal Dengue NS1
- License holder
- ARKRAY HEALTHCARE PVT. LTD.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- The ParaHIT® 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
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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