D-DIMER - India CDSCO Medical Device Registration

D-DIMER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_041f6a8759852bba9dc4bd4afafebf83_77085a23347649f62232f722f1e12be5. 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

UID: IMP/IVD/2019/000040_041f6a8759852bba9dc4bd4afafebf83_77085a23347649f62232f722f1e12be5

Brand Name

COULTER LH Series Pak Reagent Kit

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Immuno-turbidimetric test for the quantitative determination of D-Dimer in human plasma on Beckman Coulter AU analysers

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