Prealbumin Calibrator - India CDSCO Medical Device Registration

Prealbumin Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_f9182ee2bfe18e71f058d2c7f71bf80a_6122acdfaf18542367d6f7d661d320cc. This device is marketed under the brand name COULTER LH Series Pak Reagent Kit. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Prealbumin Calibrator

UID: IMP/IVD/2019/000040_f9182ee2bfe18e71f058d2c7f71bf80a_6122acdfaf18542367d6f7d661d320cc

Brand Name

COULTER LH Series Pak Reagent Kit

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Prealbumin Calibrator is a liquid human serum based matrix calibrator intended to be used with the Prealbumin reagent OSR6175 for the quantitative determination of prealbumin on Beckman Coulter analysers

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