PCT Plus - India CDSCO Medical Device Registration
PCT Plus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000203_67ff0659fda5fa06d56787e154d5d3d3_190c11fb3560ca9a82323a4332db0a06. This device is marketed under the brand name QDx Instacheck™ AFP. The license holder is DiaSys Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
QDx Instacheck™ AFP
License Holder
DiaSys Diagnostics India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
QDx Instacheck™ PCT Plus is a fluorescence Immunoassay (QDx Instacheck™ AFP) for the quantitative determination of Procalcitonin (QDx Instacheck™ AFP) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of bacterial infection and sepsis. For in vitro diagnostic use only
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