Phenylalanine Detection Test - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Phenylalanine Detection Test

UID: MFG/IVD/2020/000021_eeab648116a590a0d0fd6bfa94bc6614_6dbd71b9831391449ea7d57539becd6d

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

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.

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Brand: Multigene-Multiplex Single tube format

Mylab Discovery S0lutions Pvt. Ltd

Phenylalanine Detection Test - India CDSCO Medical Device Registration

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License Holder

Device Class

Approving Authority

Product Information

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