The Salocor COVID-19 Antigen test is authorized for use using direct nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within six days of symptom onset.

For use under an Emergency Use Authorization (EUA) only for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics (IVD), unless it is terminated or revoked by the FDA (after which the test may no longer be used).

The Salocor COVID-19 test is authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived complexity tests.

This test is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Refer to the Salocor COVID-19 Antigen test instructions, quick user guide, facts sheet for patients, and fact sheets for healthcare providers for additional information.

For prescription/medical professional use only.