4 results
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57ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPITOPE DIAGNOSTICS, INC.
FDA registration
EPITOPE DIAGNOSTICS, INC.·77 products·🇺🇸 United States
EDI™ CARE™
FDA UDI
EPITOPE DIAGNOSTICS INC·00893230002032·Fecal Occult Blood Test
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
FDA Recall
Open, Classified
·Epitope Diagnostics, Inc.·Product code QKO·October 1, 2020
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
FDA Enforcement
Class II
·Ongoing·Epitope Diagnostics, Inc.·November 18, 2020