TDM Calibrator
- UID
- IMP/IVD/2021/000024_4fd15bbb3cb72a0d16e4bd5c523aac0f_255ff8d21f096c0a01444137ef12e225
- Device class
- Class C
- Brand name
- Nanopia TDM Phenobarbital
- License holder
- Kopran Laboratories Limited
- 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
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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