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  2. Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests
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Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

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Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

TEST KIT, COVID-19 AG BINAXNOWSELF TEST (2/KT 12KT/CS)

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KT/2 CS/24
SKU:
N/A

Category:

  • Covid-19
    • 30-day money-back
    • 7-day returns
    • Shipping: 2-3 Days

    Specifications for Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

    Manufacturer Abbott Rapid Dx North America LLC
    Part Number 195160K
    Application Respiratory Test Kit
    Brand BinaxNOW™
    Contents 1 Each Kit: (2) Test Cards, (2) Bottles of < 1 mL Extraction Reagent, (2) Sterile Nasal Swabs, Patient Instructions for Use and Individual Fact Sheet
    Contract Type Local
    Number of Tests 2 Tests
    Purchase Program Type Standard Purchase
    Reading Type Visual Read
    Sample Type Anterior Nasal Swab Sample
    Specialty Immunoassay
    Test Format Test Card Format
    Test Kit Type Rapid
    Test Method Lateral Flow Immunoassay
    Test Name COVID-19 Antigen Self Test
    Test Type Antigen Detection
    Time to Results 15 Minute Results
    UNSPSC Code 41116010
    Product Properties:
    • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
    • BinaxNow™ COVID-19 Antigen Self Test is for use with an FDA Emergency Use Authorization only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
    • This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or older
    • The BinaxNOW COVID-19 Antigen Self Test is intended for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting
    • All negative results should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
    • Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease
    • This test is authorized for individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests
    • 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 COVID-19
    • The BinaxNOW COVID-19 Antigen Self Test does not differentiate between SARS-CoV and SARS-CoV-2
    • Individuals who test positive with the BinaxNOW COVID-19 Antigen Self Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
    • The BinaxNOW COVID-19 Antigen Self Test is only for use under the Food and Drug Administration’s Emergency Use Authorization; this product has not been FDA cleared or approved
    • Negative results do not rule out 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
    • The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

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