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Mycobacterium Tuberculosis Molecular Detection Kit - India CDSCO Medical Device Registration

Mycobacterium Tuberculosis Molecular Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000112_31772a4def76cc6cf94090785bb3d63f_c7418fdd6397c494c459bd2b01a43393. This device is marketed under the brand name Lyo Mix. The license holder is Genetix Biotech Asia Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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 C
Mycobacterium Tuberculosis Molecular Detection Kit
UID: MFG/IVD/2020/000112_31772a4def76cc6cf94090785bb3d63f_c7418fdd6397c494c459bd2b01a43393

Brand Name

Lyo Mix

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The Smart Sure™ MTB Screening Kit is an in vitro diagnostic (Lyo Mix) kit intended for the qualitative detection of DNA of all members of Mycobacterium tuberculosis complex in human sputum, bronchoalveolar lavage (Lyo Mix) fluid, other body fluids, and tuberculosis culture media using real-time polymerase chain reaction (Lyo Mix).

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