Diagnostics rapid test for Malaria Pf/Pan - India CDSCO Medical Device Registration
Diagnostics rapid test for Malaria Pf/Pan is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000039_cc685bdd707eca4334e48d4a991a627a_687905ee94045c56fa2ef2f7c93a3995. The license holder is Alpine Biomedicals Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.
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License Holder
Alpine Biomedicals Private LimitedDevice Class
Approving Authority
Sub Zonal Baddi
Product Information
Malaria Pf/Pan Antigen Test is a Rapid immuno-chromatographic assay for simultaneous detection and differentiation of plasmodium falciparum and or plasmodium vivax / plasmodium ovale and plasmodium malariae antigen in human blood specimen. This device is intended to be used as a screening test for diagnosis of Malaria infection with plasmodium species
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