{"product_id":"control-tyfast-flu-a-b-covid-19-positive-level-negative-level-20-swabs","title":"CorDx Tyfast Flu A\/B COVID-19 Multiplex Quality Control Swabs","description":"\u003cul\u003e\n\u003cli\u003eCorDx Tyfast Flu A\/B \u0026amp; COVID-19 Multiplex Control Swab Kit is intended to be used for quality control testing of the CorDx Tyfast Flu A\/B \u0026amp; COVID-19 Multiplex Rapid Test - CONTROLS ONLY\u003c\/li\u003e\n\u003cli\u003eThe CorDx Tyfast Flu A\/B \u0026amp; COVID-19 Multiplex Rapid Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization: https:\/\/www.fda.gov\/medical-devices\/covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2\u003c\/li\u003e\n\u003cli\u003eThe CorDx Tyfast Flu A\/B \u0026amp; COVID-19 Multiplex Rapid Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests\u003c\/li\u003e\n\u003cli\u003eThe test provides an efficient and accurate diagnostic solution in 10 mins, giving healthcare providers and communities a rapid and reliable way to prioritize their health\u003c\/li\u003e\n\u003cli\u003eTesting 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\u003c\/li\u003e\n\u003cli\u003eThis 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\u003c\/li\u003e\n\u003cli\u003eResults are for the simultaneous in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens\u003c\/li\u003e\n\u003cli\u003ePositive results do not rule out bacterial infection or co-infection with other viruses\u003c\/li\u003e\n\u003cli\u003eNegative results do not rule out influenza or SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks\u003c\/li\u003e\n\u003cli\u003eNegative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with each respiratory infection\u003c\/li\u003e\n\u003cli\u003eKit contains: 10 Positive Control Swabs, 10 Negative Control Swabs and an IFU\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"CorDx Inc","offers":[{"title":"Box","offer_id":42907736015057,"sku":"CUS294-10_BX","price":32.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0626\/7636\/9617\/files\/1258669_ppkgleft.jpg?v=1766140450","url":"https:\/\/behope.com\/products\/control-tyfast-flu-a-b-covid-19-positive-level-negative-level-20-swabs","provider":"BeHope","version":"1.0","type":"link"}