D-Dimer Calibrator - India CDSCO Medical Device Registration

D-Dimer Calibrator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000345_c23d130cbb531c1f555119f56c339428_21a6446567cb863aba545b2d6ebdcaa7. This device is marketed under the brand name D-Dimer . The license holder is Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

D-Dimer Calibrator

UID: IMP/IVD/2019/000345_c23d130cbb531c1f555119f56c339428_21a6446567cb863aba545b2d6ebdcaa7

Brand Name

D-Dimer

License Holder

Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor

Device Class

Class B

Approving Authority

CDSCO

Product Information

The D-Dimer Calibrator is a lyophilised calibrator in a human serum matrix intended to be used with the D-Dimer OSR60135 for the quantitative determination of D-Dimer in human plasma on Beckman Coulter analysers.