CARESTART COVID-19 ANTIGEN TEST RCHM-02071

Intended Use:

The CareStartCOVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test 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 not been FDA cleared or approved, but
has been authorized by FDA under an EUA for use by
authorized laboratories;
ï‚· This product has been authorized only for the detection
of proteins from SARS-CoV-2, not for any other viruses
or pathogens; and
ï‚· 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 COVID-19
under Section 564(b)(1) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the
declaration is terminated or authorization is revoked
sooner.

PLEASE NOTE: Information above in this section might be an overall summary about the product line and not in regards to the specific product. If you have any questions, Please E-mail or Call 1-877-WILBURN (1-877-945-2876).