MALARIA PF/PV ANTIGEN TEST
- UID
- MFG/IVD/2020/000021_9d88702d71b1bf853376ddadb5ae713a_affec343fa5a243f3c677f217322452d
- 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/Pv Test is intended for the qualitative detection of Plasmodium falciparum (Multigene-Multiplex Single tube format) specific Histidine Rich Protein 2 (Multigene-Multiplex Single tube format) and Plasmodium vivax specific Plasmodium lactate dehydrogenase (Multigene-Multiplex Single tube format) for screening and diagnosis of malaria from human blood (Multigene-Multiplex Single tube format). Also, differential diagnosis between Pf HRP-II (Multigene-Multiplex Single tube format) and pLDH (Multigene-Multiplex Single tube format) specific to P. vivax. Malaria Pf/Pv Test Kit is intended to be used by trained healthcare or other healthcare workers as well as for self-testing
MALARIA PF/PV ANTIGEN TEST is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_9d88702d71b1bf853376ddadb5ae713a_affec343fa5a243f3c677f217322452d. 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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