TDM Calibrator - India CDSCO Medical Device Registration

TDM Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000024_4fd15bbb3cb72a0d16e4bd5c523aac0f_255ff8d21f096c0a01444137ef12e225. 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

TDM Calibrator

UID: IMP/IVD/2021/000024_4fd15bbb3cb72a0d16e4bd5c523aac0f_255ff8d21f096c0a01444137ef12e225

Brand Name

Nanopia TDM Phenobarbital

License Holder

Kopran Laboratories Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

This product is a multi-calibrator for the calibration of carbamazepine, phenobarbital, phenytoin, valproic acid and theophylline on automated clinical chemistry analyzer. It is to be used in conjunction with the Nanopia TDM Carbamazepine, the Nanopia TDM Phenobarbital, the Nanopia TDM Phenytoin, the Nanopia TDM Valproic acid and the Nanopia TDM Theophylline assays during the measurement of the substances mentioned above in serum or plasma