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Geschäft · 20.4.20231 Min. Lesezeit
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to BioFire Defense, LLC, for the FilmArray NGDS BT-E Assay, and Biocartis NV, for the Idylla Rapid Ebola Virus Triage Test. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →