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CDSCO UID MFG/IVD/2021/000129_d67620488c89d2d2ae47820b4024c460_c08cdab178016231b8b7cc084db4580d

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

INDO-MIM Private Limited·Device Class Class C·India CDSCO·Brand: including nasopharyngeal or oropharyngeal swabs
Registration details
UID
MFG/IVD/2021/000129_d67620488c89d2d2ae47820b4024c460_c08cdab178016231b8b7cc084db4580d
Device class
Class C
Brand name
including nasopharyngeal or oropharyngeal swabs
License holder
INDO-MIM Private Limited
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.
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About this record

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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