CDSCO UID IMP/IVD/2021/000016_28a3dcbcadf99922ffc186126f24d070_b900a97fca6255fed6c80f609a92523d
High Sensitivity C-Reactive Protein (hs-CRP+CRP Fast Test Kit )
Akshat Bio Medicals Pvt Ltd·Device Class Class C·India CDSCO·Brand: PCT
Registration details
- UID
- IMP/IVD/2021/000016_28a3dcbcadf99922ffc186126f24d070_b900a97fca6255fed6c80f609a92523d
- Device class
- Class C
- Brand name
- PCT
- License holder
- Akshat Bio Medicals Pvt Ltd
- 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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About this record
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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