Covid-19 Rapid Antigen test for the Qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab Specimen - India CDSCO Medical Device Registration
Covid-19 Rapid Antigen test for the Qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab Specimen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000161_9edf710ca8e63800fbafa9e64f4094fb_aec2717363d5a144aeb8b1a143001497. 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
EzDxTM Covid 19 Rapid Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharyngeal swab specimen. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms with SARS-CoV-2 infection. It provides only an initial screening test result. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
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