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/2020/000046_5ac14208d9db7c95d381d196aa48e99a_da0d18b5265f4d1ac8eeec5e35730d53. This device is marketed under the brand name TRUSTline. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class D. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class D

Malaria Pf/Pan Ag Rapid Test

UID: MFG/IVD/2020/000046_5ac14208d9db7c95d381d196aa48e99a_da0d18b5265f4d1ac8eeec5e35730d53

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The TRUSTline Malaria Pf/Pan Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (TRUSTline) and P.vivax (TRUSTline) P.ovale (TRUSTline), or P.malariae (TRUSTline) antigens in human blood specimen. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with plasmodium. Any reactive specimen with the Trustline Malaria Pf/Pan Ag Rapid Test must be confirmed with alternative testing method(TRUSTline) and clinical findings

Class C

COVID-19 Ag Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class C

Brand: TRUSTline

Class D