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Description
Description
- CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test is for use under an FDA Emergency Use Authorization (EUA) only: 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 At Home Multiplex Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens
- This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older
- This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
- Negative results do not rule out SARS-CoV-2, influenza A, and influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks
- Easy to use design, effortless self-administration, whether at home or on the go
- Swift Clarity: Receive results rapidly in 10 minutes for early decision-making
Spécifications
Spécifications
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Product Document(s)
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ApplicationRespiratory Test Kit
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Contents 1(1) Test Cassette, (1) Swab, (1) Tube with Sample Processing Solution, (1) Quick Ref Instructions
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Number of Tests1 Test per Kit
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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 MethodImmunochromatographic Membrane Assay
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Test NameFlu A/B & COVID-19 At Home Multiplex Rapid Test
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Time to Results10 Minute Results
TyFast Flu A+B and COVID-19 Home Test FDA EUA Letter
Tyfast Flu A+B and COVID-19 Home Test IFU
Tyfast Flu A+B and COVID-19 Home Test Healthcare Providers Fact Sheet
Tyfast Flu A+B and COVID-19 Home Test Quick Ref Instructions
Return policy
Return policy
Not loving it? We offer returns for most items within 30 days of delivery for a refund or store credit.
