Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Life Technologies Corp. (a part of Thermo Fisher Scientific Inc.), for the TaqPath Monkeypox/Orthopox Virus DNA Kit, and Becton, Dickinson and Co., for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by these Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.