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

Malaria Pf/Pv Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_15b72584d6c8f9507e84bee40f25f56f_6ca555bb3e94e49b7cb0601a1ac8d759. 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/Pv Ag Rapid Test

UID: MFG/IVD/2020/000046_15b72584d6c8f9507e84bee40f25f56f_6ca555bb3e94e49b7cb0601a1ac8d759

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/Pv Ag Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (TRUSTline) and vivax (TRUSTline) antigen 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/Pv 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