Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples - India CDSCO Medical Device Registration

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_9becee6f3efe45cb9ecf50f64c58023a_a6c646b4f839b02676d62698bfe2433b. This device is marketed under the brand name Multigene-Multiplex Single tube format. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples

UID: MFG/IVD/2020/000021_9becee6f3efe45cb9ecf50f64c58023a_a6c646b4f839b02676d62698bfe2433b

Brand Name

Multigene-Multiplex Single tube format

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Detection of 2019-Novel Coronavirus/SARS-CoV-2 in respiratory specimens and sera

DJ Fang

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CMV Quantitative PCR Kit

Brand: Multigene-Multiplex Single tube format

Mylab Discovery S0lutions Pvt. Ltd

Detection of Novel Coronavirus 2019-nCoV/SARS-CoV-2 from clinical samples - India CDSCO Medical Device Registration

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Approving Authority

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