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Federal Register · Regulatory notice

Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc. for the SCoV-2 Detect Neutralizing Ab ELISA, and Roche Diagnostics for the Elecsys Anti-SARS-CoV-2. 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.

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Became public
Jun 26, 2026
Event / period date
Feb 24, 2026
Collected
Nov 8, 2026, 7:43 PM EST

Why this is connected

The source explicitly mentions BECTON DICKINSON & CO. A mention alone does not establish a financial benefit.

Source evidence

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mergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc. for the SCoV-2 Detect Neutralizing Ab ELISA, and Roche Diagnostics for the Elecsys Anti-SARS-CoV-2. 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. DATES: The revocation of the Authorizations for the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2 was effective as of February 24, 2026, InBios International, Inc.'s SCoV-2 Detect Neutralizing Ab ELISA was effective as of February 24, 2026, and Roche Diagnostics's Elecsys Anti-SARS-CoV-2 was effective as of March 2, 2026. ADDRESSES: Submit written requests for a single copy of the revocations to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903

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