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2019-nCoV - India CDSCO Medical Device Registration

2019-nCoV is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000305_d6bf561a5aab73accbdee6b72dcc97c5_dd0158af8e24326835a8d9cf5a12f97b. This device is marketed under the brand name Corona Virus RT PCR Kit. The license holder is ADT India 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.

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CDSCO Registered
Class Class C
2019-nCoV
UID: IMP/IVD/2020/000305_d6bf561a5aab73accbdee6b72dcc97c5_dd0158af8e24326835a8d9cf5a12f97b

Brand Name

Corona Virus RT PCR Kit

License Holder

ADT India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The LyteStar™ 2019-nCoV RT-PCR Kit 2.0 is intended for the specific detection of SARS-CoV-2 RNA in human respiratory specimens (Corona Virus RT PCR Kit). The LyteStar™ 2019-nCoV RT-PCR Kit 2.0 is a dual target assay comprising a screening assay targeting the E gene and a confirmation assay targeting the RdRP gene.

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