For Use Under Emergency Use Authorization (EUA) Only.
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The Accula SARS-CoV-2 Test has not been FDA cleared orapproved but has been authorized for emergency use by FDA for useby laboratories certified under the Clinical Laboratory ImprovementAmendments (CLIA) of 1988, 42 U.S.C. §263a, that meetrequirements to perform high, moderate, or waived complexity tests.The test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver,Certificate of Compliance, or Certificate of Accreditation. This testhas been authorized only for the detection of nucleic acid fromSARS-CoV-2, not for any other viruses or pathogens. Theemergency use of this test is only authorized for the duration of thedeclaration that circumstances exist justifying the authorization ofemergency use of in vitro diagnostics for detection and/or diagnosisof COVID-19 under Section 564(b)(1) of the Federal Food, Drug, andCosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration isterminated or authorization is revoked sooner.
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