Leishmania Ab Rapid Test
- UID
- IMP/IVD/2019/000307_99594fc3515a04388b5c9638d81ee02c_b187efed53b77a8b9ce351f97658517a
- Device class
- Class B
- Brand name
- RecombiLISA
- License holder
- Athenese-Dx Private Limited
- Approving authority
- CDSCO
- Product information
- The Leishmania Ab Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of Leishmania donovani (RecombiLISA), the Visceral leishmaniasis causative protozoans, in human serum or plasma. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with Visceral leishmaniasis
Leishmania Ab Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_99594fc3515a04388b5c9638d81ee02c_b187efed53b77a8b9ce351f97658517a. 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.
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