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BinaxNOW Respiratory Test Kit, Rapid Antigen Detection COVID-19 Antigen Self Test Card Format, Contents Include: (2) Test Cards, (2) Bottles of < 1 mL Extraction Reagent, (2) Sterile Nasal Swabs, Patient Instructions for Use, sold as 24/Case by Abbott Rapid Dx 195360

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Item#: Abb-195360-CS

$309.00
Item(s) Total: $309.00
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  • Product Details
  • Dealer # 1286971
    Manufacturer # 195360
    Brand or Series BinaxNOW™
    Manufacturer Name Abbott Rapid Dx North America LLC
    Country of Origin United States
    Application Respiratory Test Kit
    Contents 1 (2) Test Cards, (2) Bottles of < 1 mL Extraction Reagent, (2) Sterile Nasal Swabs, Patient Instructions for Use
    Number of Tests 2 Test per Kit
    Reading Type Visual Read
    Sample Type 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 to 30 Minute Results
    UNSPSC Code 41116144

    Features

    • The BinaxNOW™ COVID-19 Antigen Self Test is a visually read lateral flow immunoassay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19
    • COVID-19 Antigen Self Test (OTC) is 510k approved: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243518
    • This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older
    • Positive results do not rule out co-infection with other respiratory pathogens
    • Clinical Performance: 86.9% (PPA), 98.5% (NPA)
    • The BinaxNOW COVID-19 Antigen Self Test kit contains all components required to carry out an assay for SARS-CoV-2
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