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Leptospira IgG/IgM Rapid Test - India CDSCO Medical Device Registration

Leptospira IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000106_2460aa6c97d5c9356afc349e8b7840a2_7f6a15587299587b39c3a7386a9b92ce. This device is marketed under the brand name hCG. The license holder is Medlera Healthcare, and it is classified as Device Class Class B. The approving authority is Gujarat.

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.

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CDSCO Registered
Class Class B
Leptospira IgG/IgM Rapid Test
UID: MFG/IVD/2023/000106_2460aa6c97d5c9356afc349e8b7840a2_7f6a15587299587b39c3a7386a9b92ce

Brand Name

hCG

License Holder

Medlera Healthcare

Device Class

Class B

Approving Authority

Gujarat

Product Information

The Leptospira IgG/IgM Rapid test kit is a rapid immunochromatography assay for the qualitative detection and differentiation of the IgG and IgM antibodies against the Leptospira interrogans in human whole blood, serum or plasma samples

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