Leishmania Rapid Test - India CDSCO Medical Device Registration

Leishmania Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000145_f92f619ca36949e6dde57320c340dcf6_f1d368937d9a0af235d57b78e6a35d8c. This device is marketed under the brand name Scrub Typhus Detect IgG ELISA. The license holder is SIRUS BIOCARE 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 Rapid Test

UID: IMP/IVD/2019/000145_f92f619ca36949e6dde57320c340dcf6_f1d368937d9a0af235d57b78e6a35d8c

Brand Name

Scrub Typhus Detect IgG ELISA

License Holder

SIRUS BIOCARE PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Kalazar Detect™ Test for Visceral Leishmaniasis (Scrub Typhus Detect IgG ELISA) is a rapid immunochromatographic strip assay for the qualitative detection of antibodies to members of L. donovani in human serum to aid in the presumptive diagnosis of VL