Malaria PF/PV Ag Rapid Test - India CDSCO Medical Device Registration
Malaria PF/PV Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000056_10b60af7b7e415045c80226d0f5c930a_ed408315adca1a82b4b659066bc2fc6e. 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/Pv Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (NA) and vivax (NA) antigen in human blood specimen. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with plasmodium. Any reactive specimen with the Malaria Pf/Pv Ag Rapid Test must be confirmed with alternative testing method(NA) and clinical findings
