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COVID-19 Real Time PCR Kit(COVISure ) - India CDSCO Medical Device Registration

COVID-19 Real Time PCR Kit(COVISure ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000112_d5eed1c8f3dc35f2e5ed6f1218f004ac_9478d70d96270840449813376af7c949. 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
COVID-19 Real Time PCR Kit(COVISure )
UID: MFG/IVD/2020/000112_d5eed1c8f3dc35f2e5ed6f1218f004ac_9478d70d96270840449813376af7c949

Brand Name

Lyo Mix

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

COVISure is a Real Time PCR based diagnostic kit for the qualitative detection of novel coronavirus SARS Cov-2 RNA from nasopharyngeal, oropharyngeal, swabs and sputum samples from patients. It is recommended to use a standard Viral RNA extraction kit (Lyo Mix) for isolation of viral RNA. The kit is intended to be used by trained laboratory technician

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