Leptospira IgG/IgM Combo Rapid Test
- UID
- IMP/IVD/2019/000307_e56c33e47d08fc82c7bd8d48235a4b4e_5ca36fcd043bdcf944144bf7f4e0430e
- Device class
- Class B
- Brand name
- RecombiLISA
- License holder
- Athenese-Dx Private Limited
- Approving authority
- CDSCO
- Product information
- The Leptospira IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (RecombiLISA) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans
Leptospira IgG/IgM Combo Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_e56c33e47d08fc82c7bd8d48235a4b4e_5ca36fcd043bdcf944144bf7f4e0430e. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.