Mycobacterium Tuberculosis Molecular Detection Kit
- UID
- MFG/IVD/2020/000112_31772a4def76cc6cf94090785bb3d63f_c7418fdd6397c494c459bd2b01a43393
- Device class
- Class C
- Brand name
- Lyo Mix
- License holder
- Genetix Biotech Asia Pvt Ltd
- 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).
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.
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