Malaria Ag ELISA Kit
- UID
- MFG/IVD/2020/000038_93e80588e575f3c8b57b9aa76b92181e_e0c7cce34ce27c6f4dbaa5e398c02a04
- Device class
- Class D
- Brand name
- TRUSTwell
- License holder
- Athenese-Dx Private Limited
- Approving authority
- Central Drug Standard Control Organisation, South Zone
- Product information
- The Malaria Ag ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of malarial antigen (TRUSTwell) in human whole blood. It is intended for professional use only as an aid in the diagnosis of infection with Malaria parasites.
Malaria Ag ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_93e80588e575f3c8b57b9aa76b92181e_e0c7cce34ce27c6f4dbaa5e398c02a04. This device is marketed under the brand name TRUSTwell. 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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