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SARS-CoV-2 Antigen Rapid Test Kit - India CDSCO Medical Device Registration

SARS-CoV-2 Antigen Rapid Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000141_9eaf1896888156a4bef8276a51b4608e_d9e0a56292eace462b6c76c95cf023d6. This device is marketed under the brand name GeneBio. The license holder is GeneBio Healthare 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
SARS-CoV-2 Antigen Rapid Test Kit
UID: MFG/IVD/2023/000141_9eaf1896888156a4bef8276a51b4608e_d9e0a56292eace462b6c76c95cf023d6

Brand Name

GeneBio

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The โ€œGeneBio SARS-CoV-2 Antigen Rapid Test Kitโ€ is for in vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal (GeneBio) swab specimens directly from individuals who are suspected of COVID-19.

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