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VIS-1066-40 |

Respiratory Test Kit OSOM® COVID-19 Antigen 40 Tests

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About this item

  • OSOM Covid-19 Antigen Rapid Test is for use under an FDA EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
  • OSOM® COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct midturbinate (MT) nasal swab specimens from individuals who are suspected
  • Qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at l
  • For 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
  • Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine patient infection status
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • 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 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
  • OSOM Covid-19 Antigen Rapid Test is for use under an FDA EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
  • OSOM® COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct midturbinate (MT) nasal swab specimens from individuals who are suspected
  • Qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at l
  • For 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
  • Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine patient infection status
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • 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 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
  • Price: Available Upon Quote

    50+ In Stock.

    RAPID TEST, COVID 19 OSOM ANTIGEN (40/KT 12KT/CS)
    Product Specifications:
    Manufacturer #: 1066-40
    Brand: OSOM®
    Manufacturer: Sekisui Diagnostics
    Country of Origin: United States
    Application: Respiratory Test Kit
    Contents 1: (40) Test Devices containing LFI Test Strip in Plastic Housing, 2 X (20) Nasal Swab Specimen Collection and Dispensing Tubes with OSOM Antigen Buffer, IFU, Quick Ref Guide
    Number of Tests: 40 Tests
    Product Dating: McKesson Acceptable Dating: we will ship >= 60 days
    Purchase Program Type: Standard Purchase
    Reading Type: Visual Read
    Sample Type: Direct Mid-Turbinate Nasal Swab Sample
    Specialty: Immunoassay
    Test Format: Test Device Format
    Test Kit Type: Rapid
    Test Method: Lateral Flow Chromatographic Immunassay
    Test Name: Covid-19 Antigen
    Time to Results: 15 Minute Results
    *Nationwide Free Shipping: Orders must meet minimum spending threshold to quality for free shipping. **Certain product description and details, including Country of Origin, recycled content, and other product specifications, are based on information obtained from product manufacturers and other third parties. We have not independently verified this information and do not warrant its accuracy.

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