Control, Positive Level / Negative Level, For Tyfast Flu A+B / COVID-19 Multiplex Rapid Test, SOLD as 20 Swabs/Box by Tyfast, CorDx CUS294-10

Features

• CorDx Tyfast Flu A/B & COVID-19 Multiplex Control Swab Kit is intended to be used for quality control testing of the CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test - CONTROLS ONLY
• The CorDx Tyfast Flu A/B & 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
• The CorDx Tyfast Flu A/B & 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
• The 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
• 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
• Results 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
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Negative 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
• 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 each respiratory infection
• Kit contains: 10 Positive Control Swabs, 10 Negative Control Swabs and an IFU