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PCT Fast Test Kit - India CDSCO Medical Device Registration

PCT Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000410_fcf0028bd71d505b743e613a3051b357_ebf4d658d7e63db3db65a20af7c680ea. This device is marketed under the brand name Imumunofluorescence Assay. The license holder is Vector Biotek 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
PCT Fast Test Kit
UID: IMP/IVD/2019/000410_fcf0028bd71d505b743e613a3051b357_ebf4d658d7e63db3db65a20af7c680ea

Brand Name

Imumunofluorescence Assay

License Holder

Vector Biotek Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

PCT Fast Test Kit (Imumunofluorescence Assay) is intended for in vitro quantitative determination of Procalcitonin (Imumunofluorescence Assay) in serum, plasma or whole blood. The test is used as an aid in the assessment and evaluation of patients suspected of bacterial infection, trauma or shock.,hs-CRP+CRP Fast Test Kit (Imumunofluorescence Assay)(Imumunofluorescence Assay)-hs-CRP+CRP Fast Test Kit (Imumunofluorescence Assay) is intended for in vitro quantitative determination of C-reactive protein (Imumunofluorescence Assay) in serum, plasma whole blood, or fingertip blood. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury and inflammatory disorders. Measurement of high sensitivity CRP (Imumunofluorescence Assay), when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes (Imumunofluorescence Assay), may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or ACS.

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DJ Fang

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