Leishmania Ab Rapid Test - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Leishmania Ab Rapid Test

UID: IMP/IVD/2019/000307_99594fc3515a04388b5c9638d81ee02c_b187efed53b77a8b9ce351f97658517a

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

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

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Leishmania Ab Rapid Test

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Brand: RecombiLISA

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