Antigen Test Control Set IntelliSwab
COVID-19 Rapid Test Pro Positive Level / Negative Level
Orasure 1001-0613

Antigen Test Control Set IntelliSwab
COVID-19 Rapid Test Pro Positive Level / Negative Level
Orasure 1001-0613

Features The InteliSwab® COVID-19 Rapid Test Pro is for use under the Food and Drug Administration’s Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 Kit contains: InteliSwab® COVID-19 Positive Control (1 vial, blue cap, 0.25 mL), InteliSwab® COVID-19 Negative Control (1 vial, white cap, 0.25 mL), Loops (package of 5 µL loops), Instructions for use for InteliSwab® COVID-19 Rapid Test Pro Kit Controls 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 Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC Positive results indicate that viral antigens have been detected, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not exclude bacterial infection or coinfection with other viruses Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 The InteliSwab™ COVID-19 Rapid Test Pro is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in POC settings

Manufacturer # 1001-0613 Brand IntelliSwab® Manufacturer Orasure Technologies Country of Origin United States Application Control Set Container Type Vial For Use With For use with IntelliSwab COVID-19 Rapid Test Kit HCPCS U0002 Levels Positive Level / Negative Level

Storage Requirements Requires Refrigeration Test Category Respiratory Test Name COVID-19 Rapid Test Pro Test Type Antigen Test UNSPSC Code 41116205