Malaria Pf/Pv Antigen Rapid Card Test - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Malaria Pf/Pv Antigen Rapid Card Test

UID: MFG/IVD/2021/000104_6bd6422e8be0d34e3aec7e8d77428f8e_600e3ddd577e3607700c313f4d5426c6

Brand Name

HI-Quik

License Holder

Helico International

Device Class

Class C

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.