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OSOM® COVID-19 Antigen Respiratory Test Kit #1066-40

OSOM®

$416.76
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  • Rapid lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid antigen from direct mid-turbinate nasal swab specimens.
  • CLIA-waived (EUA) point-of-care cassette test providing results in 15 minutes with visual readout.
  • Each kit includes 40 tests and required components; no specialized instruments or additional reagents needed.
  • Intended for testing symptomatic patients within the first 7 days of symptom onset in authorized clinical settings.
SKU:
1232792
QTY Per Sell:
40
Number of Tests:
40 Tests
Reading Type:
Visual Read
Sample Type:
Direct Mid-Turbinate Nasal Swab Sample
Key Features:
  • CLIA-waived (EUA) rapid test
  • Mid-turbinate nasal swab sample
  • 15-minute visual results
    • Detection Method:
    Lateral flow chromatographic immunoassay
    Target Analyte:
    SARS-CoV-2 nucleocapsid antigen
    Time to Result:
    15 minutes
    CLIA Complexity:
    Waived (EUA)
    Test Format:
    Single-use cassette
    Storage Conditions:
    Store at 15–30°C (59–86°F); do not freeze
    Intended Use:
    For symptomatic individuals, tested within the first 7 days of symptom onset in authorized clinical settings.
    Performance:
  • Positive Percent Agreement: 95.1%
  • Negative Percent Agreement: 97.0%
    • Country of Origin:
    Made in the USA
    Manufacturer:
    Sekisui Diagnostics, LLC
    Manufacturer Links:
    OSOM COVID-19 Antigen Rapid Test product page: https://sekisuidiagnostics.com/product/osom-covid-19-antigen-rapid-test-eua/
    Regulatory Information:
    Authorized by FDA under an Emergency Use Authorization (EUA); not FDA cleared or approved. For use by authorized laboratories.
    SKU:
    1232792
    QTY Per Sell:
    40
    Number of Tests:
    40 Tests
    Reading Type:
    Visual Read
    Sample Type:
    Direct Mid-Turbinate Nasal Swab Sample
    ic__sync_id:
    4
    ic__id:
    7873
    Key Features:
  • CLIA-waived (EUA) rapid test
  • Mid-turbinate nasal swab sample
  • 15-minute visual results
    • Detection Method:
    Lateral flow chromatographic immunoassay
    Target Analyte:
    SARS-CoV-2 nucleocapsid antigen
    Time to Result:
    15 minutes
    CLIA Complexity:
    Waived (EUA)
    Test Format:
    Single-use cassette
    Storage Conditions:
    Store at 15–30°C (59–86°F); do not freeze
    Intended Use:
    For symptomatic individuals, tested within the first 7 days of symptom onset in authorized clinical settings.
    Performance:
  • Positive Percent Agreement: 95.1%
  • Negative Percent Agreement: 97.0%
    • Country of Origin:
    Made in the USA
    Manufacturer:
    Sekisui Diagnostics, LLC
    Manufacturer Links:
    OSOM COVID-19 Antigen Rapid Test product page: https://sekisuidiagnostics.com/product/osom-covid-19-antigen-rapid-test-eua/
    Regulatory Information:
    Authorized by FDA under an Emergency Use Authorization (EUA); not FDA cleared or approved. For use by authorized laboratories.