CRP Latex - India CDSCO Medical Device Registration

CRP Latex is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_12f7b7af0d32ea12aac3231fd7077502_1d3eb0837e65907323938ea1f53caa87. 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

CRP Latex

UID: IMP/IVD/2019/000040_12f7b7af0d32ea12aac3231fd7077502_1d3eb0837e65907323938ea1f53caa87

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 C-reactive protein (COULTER LH Series Pak Reagent Kit) in human serum and plasma on Beckman Coulter AU analysers. The normal application is to be used for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The Highly Sensitive application is not a general screening test for infection/inflammation

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