Malaria PF/PAN Ag Rapid Test - India CDSCO Medical Device Registration
Malaria PF/PAN Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000056_865fe9f6cd325e12fe60207f7014f1ac_c8cbcb86d7b8a355c8e224f6071c421b. The license holder is Biotrol Laboratories Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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License Holder
Biotrol Laboratories Pvt. Ltd.Device Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
The Malaria Pf/Pan Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (NA) antigen and P. vivax (NA), P. ovale (NA), or P. malariae (NA) antigen in human blood specimen. This device is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with plasmodium
