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Description
Description
- 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
Spécifications
Spécifications
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Product Document(s)
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ApplicationControl
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For Use WithFor Tyfast Flu A+B / COVID-19 Multiplex Rapid Test
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FormSwab
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LevelsPositive Level / Negative Level
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Test CategoryRespiratory
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Test NameFlu A+B / COVID-19
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Volume20 Swabs
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test FDA EUA Letter
Tyfast Flu A+B and COVID- 19 Multiplex Test Control Swab Kit IFU
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test Healthcare Providers Fact Sheet
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test Patients Fact Sheet
Return policy
Return policy
Not loving it? We offer returns for most items within 30 days of delivery for a refund or store credit.
