CDSCO UID IMP/IVD/2019/000040_12f7b7af0d32ea12aac3231fd7077502_1d3eb0837e65907323938ea1f53caa87

CRP Latex

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_12f7b7af0d32ea12aac3231fd7077502_1d3eb0837e65907323938ea1f53caa87
Device class: Class B
Brand name: COULTER LH Series Pak Reagent Kit
License holder: Beckman Coulter India Private Limited
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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About this record

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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