Gentamycin Calibrator - India CDSCO Medical Device Registration

Gentamycin Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000187_ae3aa214b79902ca2eb906e96e2db259_4ae63afee048db8111868ce6cbf58d55. This device is marketed under the brand name VITROS Chemistry Products AMPH Reagent. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Gentamycin Calibrator

UID: IMP/MD/2018/000187_ae3aa214b79902ca2eb906e96e2db259_4ae63afee048db8111868ce6cbf58d55

Brand Name

VITROS Chemistry Products AMPH Reagent

License Holder

M/s. Ortho Clinical Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate the VITROS Chemistry System and VITROS Integrated System for the quantitative measurement of gentamicin (VITROS Chemistry Products AMPH Reagent)

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