PR3 Antibodies ELISA Kit - India CDSCO Medical Device Registration
PR3 Antibodies ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000285_f1d148b5449b08833938e7d37d653ccb_08ef2f3c003fe127ca13459685a2964b. This device is marketed under the brand name Genarrayt Microarray 200+ food IgG. The license holder is Omega DX (Asia) Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Genarrayt Microarray 200+ food IgG
License Holder
Omega DX (Asia) Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The anti-PR3 kit is a rapid ELISA test for the detection of IgG antibodies to serine protease - 3 (Genarrayt Microarray 200+ food IgG). It is intended for use in clinical laboratories as an aid to the diagnosis of Wegener’s granulomatosis and associated diseases.
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