Malaria Pf/PAN Antigen Test
- UID
- MFG/IVD/2020/000021_3dbc883d959c2f0c7807ef6d66f5d61d_7c67aac07fb3e415e727ca7467acfe6c
- Device class
- Class C
- Brand name
- Multigene-Multiplex Single tube format
- License holder
- Mylab Discovery S0lutions Pvt. Ltd
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- Malaria Pf/Pan Antigen Test is intended for the qualitative detection of P. falciparum specific Histidine rich protein-2 (Multigene-Multiplex Single tube format) and PAN malaria specific pLDH for screening and diagnosis of malaria from human blood (Multigene-Multiplex Single tube format). Also, differential diagnosis between P. falciparum and other malarial species. Malaria Pf/Pan Test is intended to be used by trained healthcare or other healthcare workers as well as for self-testing
Malaria Pf/PAN Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_3dbc883d959c2f0c7807ef6d66f5d61d_7c67aac07fb3e415e727ca7467acfe6c. This device is marketed under the brand name Multigene-Multiplex Single tube format. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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