COVID-19 S Plus Rapid PCR Kit - India CDSCO Medical Device Registration

COVID-19 S Plus Rapid PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_8b341a5d7a4ef0fb0f05629bcc4c57bb_87d81e18f02a9af7607d93bfe8cb4686. 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

COVID-19 S Plus Rapid PCR Kit

UID: MFG/IVD/2020/000021_8b341a5d7a4ef0fb0f05629bcc4c57bb_87d81e18f02a9af7607d93bfe8cb4686

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

Mylab Discovery Solutions CoviSwiftTM COVID-19 S Plus Rapid PCR Kit is intended to use as an in vitro real time PCR test for rapid detection of Novel Coronavirus (Multigene-Multiplex Single tube format) directly from respiratory specimens without RNA extraction. The kit is also intended to identify S drop out due to deletion in spike protein at 69-70 amino acid position

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Brand: Multigene-Multiplex Single tube format

Mylab Discovery S0lutions Pvt. Ltd

COVID-19 S Plus Rapid PCR Kit - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

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