federal_register: 2024-10910
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
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| 2024-10910 | Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability | Notice | The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg S.[aacute].r.l. (A Siemens Healthineers Company), for the FTD SARS-CoV- 2. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document. | 2024-05-17 | 2024 | 5 | https://www.federalregister.gov/documents/2024/05/17/2024-10910/revocation-of-two-authorizations-of-emergency-use-of-in-vitro-diagnostic-device-for-detection-andor | https://www.govinfo.gov/content/pkg/FR-2024-05-17/pdf/2024-10910.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg... |