Phenytoin kit - India CDSCO Medical Device Registration

Phenytoin kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000024_e5459df0ad0578795023f0d68e82b9c5_ba2a7a8e0888666517777b61764022f9. This device is marketed under the brand name Nanopia TDM Phenobarbital. The license holder is Kopran Laboratories Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Phenytoin kit

UID: IMP/IVD/2021/000024_e5459df0ad0578795023f0d68e82b9c5_ba2a7a8e0888666517777b61764022f9

Brand Name

Nanopia TDM Phenobarbital

License Holder

Kopran Laboratories Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

Measurement of phenytoin in serum or plasma

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