Item Brochure

The Sofia SARS Antigen FIA is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the Sofia, Sofia 2 and Sofia Q
instruments. The Sofia SARS Antigen FIA is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The Sofia SARS Antigen FIA should be used with Sofia, Sofia 2.
In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a,
that meet requirements to perform to perform moderate, high or waived complexity tests. This product is 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.
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, In the USA, - the emergency use of this product is only authorized for the
duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner
ASSISTANCE
If the Sofia, Sofia 2 or the assay do not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.), [e-mail], or your local
distributor.
Quidel Corporation
San Diego, CA 92121 USA
quidel.com
1439005EN00 (04/21)
Reference the Package Insert for Warnings and Precautions, Limitations, Specimen Collection and Handling, and Quality Control.
Study the Package Insert and User Manual thoroughly
before using Quick Reference Instructions. This is not a
complete Package Insert.