Malaria Pf/PAN Rapid Test Kit - India CDSCO Medical Device Registration

Malaria Pf/PAN Rapid Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000068_ab65f0c2b4a6a14556b3a418eafe420a_0d50910e08021ee5053c16ab815c0f0c. This device is marketed under the brand name PathKits Simple COVID-19 Ag Rapid Kit. The license holder is PATHKITS HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

Malaria Pf/PAN Rapid Test Kit

UID: MFG/IVD/2021/000068_ab65f0c2b4a6a14556b3a418eafe420a_0d50910e08021ee5053c16ab815c0f0c

Brand Name

PathKits Simple COVID-19 Ag Rapid Kit

License Holder

PATHKITS HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

It is a rapid qualitative and sensitive chromatographic immunoassay based on antigen detection. It is as an aid in differential identification of infection with HRP-2 (PathKits Simple COVID-19 Ag Rapid Kit) specific P. falciparum and pLDH (PathKits Simple COVID-19 Ag Rapid Kit) specific Plasmodium sp. (PathKits Simple COVID-19 Ag Rapid Kit) in human whole blood specimens