Rapid Malaria Pf/PAN Ag Test - India CDSCO Medical Device Registration
Rapid Malaria Pf/PAN Ag Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000068_2d0abf1ef9cb0175a31a9daaf7a9d6ee_7925ffcd0ed8277fdbd37238270fb9b9. This device is marketed under the brand name Pf-HRPII/PAN-pLDH. The license holder is Oxalis Diagnostics Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
Pf-HRPII/PAN-pLDH
License Holder
Oxalis Diagnostics Pvt. LtdDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
Rapid Malaria Pf/PAN (Pf-HRPII/PAN-pLDH) Ag Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum and P. vivax (Pf-HRPII/PAN-pLDH), P. ovale (Pf-HRPII/PAN-pLDH), or P. malariae (Pf-HRPII/PAN-pLDH) 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. The test is intended for professional use. Any reactive specimen with rapid Malaria Pf/PAN Ag test must be confirmed with alternative testing method(Pf-HRPII/PAN-pLDH) and clinical findings
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