HIgh Sensitivity C-Reactive Protein (One step test for hs CRP+CRP ) - India CDSCO Medical Device Registration

HIgh Sensitivity C-Reactive Protein (One step test for hs CRP+CRP ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000236_6e68374682591f8311f581592f6aa7d1_63721b79e31ae45190e361818c1e2f0a. This device is marketed under the brand name Beta 2 - MG. The license holder is Cosmic Scientific Technologies, 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 (One step test for hs CRP+CRP )

UID: IMP/IVD/2020/000236_6e68374682591f8311f581592f6aa7d1_63721b79e31ae45190e361818c1e2f0a

Brand Name

Beta 2 - MG

License Holder

Cosmic Scientific Technologies

Device Class

Class C

Approving Authority

CDSCO

Product Information

One step test for hs CRP+CRP (Beta 2 - MG) is intended for in vitro quantitative determination of C-reactive protein (Beta 2 - MG) in serum, plasma, whole blood or finguretip blood. Measurement of CRP is useful for detection and evaluation of infection, tissue injury and inflammatory disorders. Measurement of high high sensivity CRP (Beta 2 - MG), when use in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome (Beta 2 - MG), may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or ACS