Malaria Pf/Pan Ag Rapid Test
- UID
- MFG/IVD/2020/000046_5ac14208d9db7c95d381d196aa48e99a_da0d18b5265f4d1ac8eeec5e35730d53
- Device class
- Class D
- Brand name
- TRUSTline
- License holder
- Athenese-Dx Private Limited
- 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
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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