federal_register: 2022-05310
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-05310 | Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices 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 LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions Medical Corporation for the Omni COVID-19 Assay by RT-PCR. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document. | 2022-03-14 | 2022 | 3 | https://www.federalregister.gov/documents/2022/03/14/2022-05310/revocation-of-two-authorizations-of-emergency-use-of-in-vitro-diagnostic-devices-for-detection-andor | https://www.govinfo.gov/content/pkg/FR-2022-03-14/pdf/2022-05310.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 LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions... |