D-Dimer Control - India CDSCO Medical Device Registration

D-Dimer Control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000345_e986fdb6b87dd77910f0256eafcd1471_6df018d395b082cf64de1ef8f2a8b860. 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 Control

UID: IMP/IVD/2019/000345_e986fdb6b87dd77910f0256eafcd1471_6df018d395b082cf64de1ef8f2a8b860

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 Control is a lyophilised control in a human serum matrix intended to be used to monitor the analytical performance of the D-Dimer OSR60135 on Beckman Coulter analysers