Client: SIMON MALL-SAWGRASS SUNRISE Accession: B02532503 Spec Type: SWAB Initial Report Date: 10/12/2020 Final Report Date: 10/12/2020 1 Industry Dr., Henderson, NC 27537 Phone: 252-572-2795; Fax: 252-572-4595 CLIA ID: 34D2141858 Order Information Account Information: Patient Information: DUENAS CARDENAS, MARTHA Date of Birth: Gender: Patient ID: Phone: Collected: Address: Acct #: Test Information: 12517 720100: SARS-CoV-2 10/12/1975 Female Race: Clinician: RITA SMITH Location: SUNRISE, FL 33323 Collector: 786-229-0176 Requisition: MX517F7DF6028 10/09/2020 13:01 Received: 10/12/2020 02:19 15298 SOUTHWEST 17TH TERRACE, MIAMI, FL 33185 Diagnosis Codes: Diagnosis Codes Not Provided Medications: No Medications Indicated Comments: RESULT SARS-CoV-2 (Abnormal) FLAG UOM REFERENCE RANGE LOC Not Detected Negative (Not Detected) The SARS-CoV-2 test is intended for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens. A Negative result does not exclude infection caused by SARS-CoV-2 and the results must be correlated with clinical presentation and evaluated in the context of other laboratory and epidemiologic data. The COVID-19 RT-qPCR test is a Laboratory Developed test (LDT) not approved or cleared by the FDA and has been approved for Emergency Use Authorization (EUA). This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. (1) Test Performed at: Mako Medical - Henderson 1 Industry Dr. Henderson, NC, 27537 Director: Chad R. Rund, D.O., FCAP 34D2141858 *** Final Report *** Accession #: B02532503 DUENAS CARDENAS, MARTHA Page: 1/1 RESULTED: 10/12/2020 08:03
