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/2019/000040_e986fdb6b87dd77910f0256eafcd1471_6df018d395b082cf64de1ef8f2a8b860. 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

D-Dimer Control

UID: IMP/IVD/2019/000040_e986fdb6b87dd77910f0256eafcd1471_6df018d395b082cf64de1ef8f2a8b860

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 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

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