CDSCO UID MFG/IVD/2021/000104_6bd6422e8be0d34e3aec7e8d77428f8e_600e3ddd577e3607700c313f4d5426c6

Malaria Pf/Pv Antigen Rapid Card Test

Helico International·Device Class Class C·India CDSCO·Brand: HI-Quik
Registration details
UID
MFG/IVD/2021/000104_6bd6422e8be0d34e3aec7e8d77428f8e_600e3ddd577e3607700c313f4d5426c6
Device class
Class C
Brand name
HI-Quik
License holder
Helico International
Approving authority
Sub Zonal Bangalore
Product information
The HI-Quik MALARIA p.f /Pv antigen rapid card test kit is an immunochromatographic based assay for the qualitative detection of antigen specific to Plasmodium falciparum (HI-Quik) and Plasmodium vivax pLDH from human whole blood samples. (Plasmodium lactate dehydrogenase (HI-Quik) specific to Malaria P.v P.m P.o. and HRP II antigens specific to P. f in human whole blood). The test may also be used for the differentiation of P. falciparum and P. vivax infection.
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About this record

Malaria Pf/Pv Antigen Rapid Card Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000104_6bd6422e8be0d34e3aec7e8d77428f8e_600e3ddd577e3607700c313f4d5426c6. This device is marketed under the brand name HI-Quik. The license holder is Helico International, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.

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