Anti PR-3 - India CDSCO Medical Device Registration
Anti PR-3 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000078_e47d6cb1a83354c04dc5ac415c0c78cf_59eb8ee8858248f2572726cc059cb36b. This device is marketed under the brand name p-ANCA. The license holder is M/s Vishat Diagnostic Pvt Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
p-ANCA
License Holder
M/s Vishat Diagnostic Pvt Ltd.Device Class
Approving Authority
CDSCO
Product Information
Indirect solid phase enzyme immunoassay (p-ANCA) for the quantitative measurement of IgG class autoantibodies against proteinase 3 (p-ANCA) in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of certain autoimmune vasculitides such as Wegener´s granulomatosis
