Phenylalanine Detection Test
- UID
- MFG/IVD/2020/000021_eeab648116a590a0d0fd6bfa94bc6614_6dbd71b9831391449ea7d57539becd6d
- 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
- The kit is a quantitative chemical method for determination of Phenylalanine concentration in Dried blood spots (Multigene-Multiplex Single tube format) intended for screening of Phenylketonuria (Multigene-Multiplex Single tube format) in newborns.
Phenylalanine Detection Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_eeab648116a590a0d0fd6bfa94bc6614_6dbd71b9831391449ea7d57539becd6d. 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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