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CDSCO UID MFG/IVD/2022/000009_fa7ba88eb74e962780f7ed681189dc93_0fddcba0b215a1d6a45993995ab89f99

DIAGNOSTICS TEST REAGENT /KITS FOR MALARIA Pv/Pf

Vimek Bioconcept Pvt Ltd·Device Class Class C·India CDSCO·Brand: Covid-19 RT PCR
Registration details
UID
MFG/IVD/2022/000009_fa7ba88eb74e962780f7ed681189dc93_0fddcba0b215a1d6a45993995ab89f99
Device class
Class C
Brand name
Covid-19 RT PCR
License holder
Vimek Bioconcept Pvt Ltd
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 Pv malaria specific pLDH from human whole blood samples. The test may also be used for the differentiation of P.falciparum and P.vivax species and for the follow up of anti-malarial therapy in whole blood samples
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About this record

DIAGNOSTICS TEST REAGENT /KITS FOR MALARIA Pv/Pf is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000009_fa7ba88eb74e962780f7ed681189dc93_0fddcba0b215a1d6a45993995ab89f99. 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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