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HCV qualitative RT-PCR kit - India CDSCO Medical Device Registration

HCV qualitative RT-PCR kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000112_36a3951d4e140d6cad947c191380a7a5_a5ce3b94391bbf550e55d2d3b9019f2f. 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
HCV qualitative RT-PCR kit
UID: MFG/IVD/2020/000112_36a3951d4e140d6cad947c191380a7a5_a5ce3b94391bbf550e55d2d3b9019f2f

Brand Name

Lyo Mix

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

It is intended to be used as an in vitro diagnostic kit for detecting HCV RNA (Lyo Mix) in serum or plasma samples using a real-time PCR thermal cycler. This kit also contains the RNase P gene as an internal control (Lyo Mix) to check the quality of extracted viral RNA from the biological samples. The final analytical data of HCVSure should be interpreted and correlated with the clinical history and findings

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