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 MFG/IVD/2021/000109_99594fc3515a04388b5c9638d81ee02c_52924ebc1857b59b0771b47591a58dd5. This device is marketed under the brand name 3 Parameters. The license holder is Biotrol Laboratories Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is West Delhi Division.

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CDSCO Registered

Class Class B

Leishmania Ab Rapid Test

UID: MFG/IVD/2021/000109_99594fc3515a04388b5c9638d81ee02c_52924ebc1857b59b0771b47591a58dd5

Brand Name

3 Parameters

License Holder

Biotrol Laboratories Pvt. Ltd.

Device Class

Class B

Approving Authority

West Delhi Division

Product Information

The Leishmania Ab Rapid Test is a lateral flow immunoassay for the qualitative detection of the antibodies specific to leishmanial speciies (3 Parameters), the visceral leishmaniasis causative protozoans in human serum, plasma and whole blood. It is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of the disease of visceral leishmaniasis

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Leishmania Ab Rapid Test

Brand: HaemNest Sheath Fluid

Genenest Biotech Pvt. Ltd.

Class B

Brand: 3 Parameters

Biotrol Laboratories Pvt. Ltd.

Class B

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Leishmania Ab Rapid Test - India CDSCO Medical Device Registration

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License Holder

Device Class

Approving Authority

Product Information

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