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Description
Description
- 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
- Product ships with minimum 90 days dating
- 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
Spécifications
Spécifications
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Product Document(s)
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test FDA EUA Letter
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test 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 Healthcare Providers Fact Sheet
TyFast Flu A+B & COVID-19 Multiplex Rapid Test Sell Sheet
SDS
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ApplicationRespiratory Test Kit
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Contents 1(25) Test Cassettes, (25) Swabs, (25) Tubes with Sample Processing Solution, IFU, Quick Ref Guide
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Number of Tests25 Tests
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Purchase Program TypeStandard Purchase
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Reading TypeVisual Read
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Sample TypeAnterior Nasal Swab Sample
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SpecialtyImmunoassay
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Test FormatCassette Format
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Test Kit TypeRapid
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Test MethodLateral Flow
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Test NameFlu A+B / COVID-19 Multiplex Rapid Test
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Time to Results10 Minute Results
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test FDA EUA Letter
CorDx Tyfast Flu A+B and COVID-19 Multiplex Rapid Test 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 Healthcare Providers Fact Sheet
TyFast Flu A+B & COVID-19 Multiplex Rapid Test Sell Sheet
SDS
Return policy
Return policy
Not loving it? We offer returns for most items within 30 days of delivery for a refund or store credit.
