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High Sensitivity C-Reactive Protein (hs-CRP+CRP Fast Test Kit ) - India CDSCO Medical Device Registration

High Sensitivity C-Reactive Protein (hs-CRP+CRP Fast Test Kit ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000016_28a3dcbcadf99922ffc186126f24d070_b900a97fca6255fed6c80f609a92523d. This device is marketed under the brand name PCT. The license holder is Akshat Bio Medicals Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
High Sensitivity C-Reactive Protein (hs-CRP+CRP Fast Test Kit )
UID: IMP/IVD/2021/000016_28a3dcbcadf99922ffc186126f24d070_b900a97fca6255fed6c80f609a92523d

Brand Name

PCT

Device Class

Class C

Approving Authority

CDSCO

Product Information

hs CRP+CRP Fast Test Kit (PCT) is intended for in vitro quantitative determination of C-reactive protein (PCT) in serum, plasma, whole blood or figure tip blood. Measurement of CRP is useful for detection and evaluation of infection, tissue injury and inflammatory disorders. Measurement of high sensivity CRP (PCT), when use in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome (PCT), may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or ACS

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