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DIAGNOSTICS TEST REAGENT/ KITS FOR MALARIA Pan/Pf - India CDSCO Medical Device Registration

DIAGNOSTICS TEST REAGENT/ KITS FOR MALARIA Pan/Pf is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000009_e0744ce087f0eaace6dfcd81acdfcddb_aeef2cd56e81b887cb34b21a9ad89b47. This device is marketed under the brand name Covid-19 RT PCR. The license holder is Vimek Bioconcept Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered
Class Class C
DIAGNOSTICS TEST REAGENT/ KITS FOR MALARIA Pan/Pf
UID: MFG/IVD/2022/000009_e0744ce087f0eaace6dfcd81acdfcddb_aeef2cd56e81b887cb34b21a9ad89b47

Brand Name

Covid-19 RT PCR

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

This is a rapid, in vitro, qualitative lateral flow immunoassay for the detection of P.falciparum specific Histidine rich protein-2 ( Covid-19 RT PCR) and PAN malaria specific pLDH from human whole blood samples. The test may also be used for the differentiation of P.falciparum and other malarial species and for the follow up of anti-malarial therapy in whole blood samples

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