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Entreprise · 02/01/20261 min de lecture
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →
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