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

Malaria Antigen test kits for PF, PAN(Indo-Medx Malaria Pf / PAN Antigen Test) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000129_aead5bfaf3d04e4dc1f0651a8c657efb_ef50f52681dd4ce13d986525f24f59b8. 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, PAN(Indo-Medx Malaria Pf / PAN Antigen Test)

UID: MFG/IVD/2021/000129_aead5bfaf3d04e4dc1f0651a8c657efb_ef50f52681dd4ce13d986525f24f59b8

Brand Name

including nasopharyngeal or oropharyngeal swabs

License Holder

INDO-MIM Private Limited

Device Class

Class C

Approving Authority

Sub Zonal Bangalore

Product Information

Indo-Medx Malaria Pf (including nasopharyngeal or oropharyngeal swabs)/ PAN (including nasopharyngeal or oropharyngeal swabs) Antigen Test 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 PAN malaria specific pLDH from human whole blood samples. The test may also be used for the differentiation of P. falciparum and other malarial species and for the follow up of anti-malarial therapy in whole blood samples