Calprotectin - India CDSCO Medical Device Registration
Calprotectin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000084_ea21f3e37ebf35ae5d3d68b392aeaf74_990866a02944554ce10ee3461291cde6. This device is marketed under the brand name Orgentec. The license holder is Weldon Biotech India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Orgentec
License Holder
Weldon Biotech India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
Calprotectin is an ELISA-based test system for the quantitative measurement of calprotectin in human stool samples to be used in the assessment of intestinal inflammatory disorders. This product is intended for professional in vitro diagnostic use only
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