Covid -19 IgG/IgM rapid antibody test for detection of IgG and IgM antibodies in human serum/plasma/Whole blood - India CDSCO Medical Device Registration
Covid -19 IgG/IgM rapid antibody test for detection of IgG and IgM antibodies in human serum/plasma/Whole blood is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000161_77018fc72f2fd559b5c1d0ea07877631_c1ca2954ab29dac396dbf85c1ef63ff5. This device is marketed under the brand name EzDx. The license holder is ADVY CHEMICAL PVT. LTD., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
EzDx
License Holder
ADVY CHEMICAL PVT. LTD.Device Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
EzDx COVID-19 antibody detection rapid kit is a rapid and qualitative immune-chromatographic in vitro assay for the differential detection of IgM & IgG antibodies to COVID-19 virus in human serum, plasma/whole blood samples obtained from patient with signs and symptoms of respiratory infection. It is designed for qualitative detection of Immunoglobulin G and Immunoglobulin M antibody of Novel Coronavirus (EzDx) in human blood. The test is intended for professional and laboratory use
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