Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to BillionToOne, Inc. for the qSanger-COVID-19 Assay, RTA Laboratories Biological Products Pharmaceutical and Machinery Industry (RTA) for the Diagnovital SARS-CoV-2 Real-Time PCR Kit, DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, and CENTOGENE US, LLC for both the CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR Assay. 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.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.