Malaria Antigen test kits for PF, PV(Indo-Medx Rapid Malaria Pf /Pv Antigen Test) - India CDSCO Medical Device Registration

Malaria Antigen test kits for PF, PV(Indo-Medx Rapid Malaria Pf /Pv Antigen Test) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000129_d67620488c89d2d2ae47820b4024c460_c08cdab178016231b8b7cc084db4580d. This device is marketed under the brand name including nasopharyngeal or oropharyngeal swabs. The license holder is INDO-MIM Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.

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CDSCO Registered

Class Class C

Malaria Antigen test kits for PF, PV(Indo-Medx Rapid Malaria Pf /Pv Antigen Test)

UID: MFG/IVD/2021/000129_d67620488c89d2d2ae47820b4024c460_c08cdab178016231b8b7cc084db4580d

Brand Name

including nasopharyngeal or oropharyngeal swabs

License Holder

INDO-MIM Private Limited

Device Class

Class C

Approving Authority

Sub Zonal Bangalore

Product Information

Malaria Antigen test kits for PF, PV is a rapid, in vitro, qualitative lateral flow immunoassay for the detection of P.falciparum specific histidine rich protein-2 (including nasopharyngeal or oropharyngeal swabs) and P. vivax specific pLDH from human whole blood samples. The test may also be used for the differentiation of P. falciparum and P. vivax infection.