Genehmigung der Notfallnutzung eines In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Verfügbarkeit

Zusammenfassung

Die Food and Drug Administration (FDA or Agency) gibt die Erteilung einer Emergency Use Authorization (EUA) (die Authorizations) im Rahmen des Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of Mpox bekannt. Die FDA hat eine Authorizing for an in vitro diagnostic device, Allplex HSV-1&2/VZV/ MPXV Assay, issued for the simultaneous qualitative detection and differentiation of viral nucleic acid from monkeypox virus (MPXV clade I/II and MPX V clade II)1, herpes simplex virus type 1 (HSV-1), herpes simpleks virus type 2 (HSv-2), and