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

COVID-19 Real Time PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000112_bdd2dba94c8644c78c30bf48d793a7f7_4ada3a22fb0251d65b318814ead0d0f7. 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
UID: MFG/IVD/2020/000112_bdd2dba94c8644c78c30bf48d793a7f7_4ada3a22fb0251d65b318814ead0d0f7

Brand Name

Lyo Mix

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

COVISure Media Direct Extraction Covid-19 Real Time PCR kit is used for the qualitative detection of novel coronavirus SARS Cov-2 RNA directly from nasopharyngeal, oropharyngeal Swabs/VTM, skipping the tedious RNA extraction procedure. COVISure Media Direct Extraction kit with its unique inhibitor tolerant properties allows amplification of difficult samples, and fast cycling properties help reduce the turnaround time for the detection of novel SARS nCoV-2. The kit supplied with Direct Extraction Buffer and user-friendly protocol. This kit is intended for use by laboratory trained personnel

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