COVID-19 S Plus Rapid PCR Kit
- UID
- MFG/IVD/2020/000021_8b341a5d7a4ef0fb0f05629bcc4c57bb_87d81e18f02a9af7607d93bfe8cb4686
- Device class
- Class C
- Brand name
- Multigene-Multiplex Single tube format
- License holder
- Mylab Discovery S0lutions Pvt. Ltd
- 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
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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