federal_register: 2017-13666

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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
2017-13666 Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus Notice The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the LightMix[supreg] Zika rRT-PCR Test. FDA revoked this Authorization on March 13, 2017, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. by letter dated March 10, 2017. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document. 2017-06-30 2017 6 https://www.federalregister.gov/documents/2017/06/30/2017-13666/revocation-of-authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-of-zika https://www.govinfo.gov/content/pkg/FR-2017-06-30/pdf/2017-13666.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 Authorization (EUA) (the Authorization) issued to Roche Molecular Systems, Inc. for the LightMix[supreg] Zika rRT-PCR Test. FDA revoked this Authorization on March...  

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