Malaria Pf/Pan Ag Rapid Test - India CDSCO Medical Device Registration

Malaria Pf/Pan Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000095_5ac14208d9db7c95d381d196aa48e99a_d5a60cabf37462954a58ffa6a34318aa. This device is marketed under the brand name Sensit Rapid. The license holder is Ubio Biotechnology Systems Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Malaria Pf/Pan Ag Rapid Test

UID: MFG/IVD/2020/000095_5ac14208d9db7c95d381d196aa48e99a_d5a60cabf37462954a58ffa6a34318aa

Brand Name

Sensit Rapid

License Holder

Ubio Biotechnology Systems Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Sensit Malaria P.f/Pan Antigen Rapid Test Kit is qualitative immunochromatographic assay for the simultaneous detection and differentiation of P. falciparum and P. vivax, P. ovale, and P.malariaein human blood. This test ensures a differential diagnosis by detecting the proteins produced, P.f HRP-II (Sensit Rapid), and Pan LDH (Sensit Rapid). Sensit Malaria P.f/Pan Antigen Rapid Test is only intended for initial screening and reactive samples should be confirmed by a supplemental assay such as P.f/Pan ELISA or HI (Sensit Rapid) test