COVID-19 Real Time PCR Kit(SMARTCHEK® Novel Coronavirus Detection Kit) - India CDSCO Medical Device Registration

COVID-19 Real Time PCR Kit(SMARTCHEK® Novel Coronavirus Detection Kit) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000122_891454d7441b03d48f1aca22e7bf1c49_a1c88c036bdf06a8352575dbcd28f967. This device is marketed under the brand name SARS-CoV-2. The license holder is Genetix Biotech Asia Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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.

Free Database

CDSCO Registered

Class Class C

COVID-19 Real Time PCR Kit(SMARTCHEK® Novel Coronavirus Detection Kit)

UID: IMP/IVD/2021/000122_891454d7441b03d48f1aca22e7bf1c49_a1c88c036bdf06a8352575dbcd28f967

Brand Name

SARS-CoV-2

License Holder

Genetix Biotech Asia Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

SMARTCHEK® novel coronavirus (SARS-CoV-2) detection kit is based on biochip sample format and provides relatively short turn-around-time with simple workflow while it offers key benefits of real-time PCR tests. This kit is intended for in vitro diagnostic use.

Class C

Brand: Debrisoft® Lolly

Class C