CDSCO UID IMP/IVD/2019/000040_e986fdb6b87dd77910f0256eafcd1471_6df018d395b082cf64de1ef8f2a8b860

D-Dimer Control

Beckman Coulter India Private Limited·Device Class Class B·India CDSCO·Brand: COULTER LH Series Pak Reagent Kit

Registration details

UID: IMP/IVD/2019/000040_e986fdb6b87dd77910f0256eafcd1471_6df018d395b082cf64de1ef8f2a8b860
Device class: Class B
Brand name: COULTER LH Series Pak Reagent Kit
License holder: Beckman Coulter India Private Limited
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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About this record

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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