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VIS-20377 |

Respiratory Test Kit Sofia® 2 Flu + SARS Antigen FIA 25 Tests CLIA Waived

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About this item

  • For use on Sofia 2 analyzers ONLY - test cannot be run on a Sofia 1 analyzer; reach out to your account manager with any analyzer questions or requests
  • Sofia 2 Flu + SARS Antigen FIA is for use under an FDA EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Product ships with minimum 60 days dating
  • Emergency use of this test is limited to Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S
  • The Sofia 2 Flu + SARS FIA is intended to be used with direct nasal or nasopharyngeal swabs and is not validated for use with viral transport media
  • The test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses a
  • 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
  • Laboratories within the United States and its territories are required to report all SARS-CoV-2results to the appropriate public health authorities
  • Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions; negative results should be considered in the context of a patient’s recent exposu
  • Negative SARS-CoV-2 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
  • The Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument; the Sofia 2 Flu + SARS Antigen FIA test is only for use
  • Accurate detection with direct samples
  • Results in 15 minutes
  • Price: Available Upon Quote

    50+ In Stock.

    TEST KIT, SOFIA FLU & SARS ANTIGEN FIA ASSY (25/KT 12KT/CS)
    Product Specifications:
    Manufacturer #: 20377
    Brand: Sofia® 2
    Manufacturer: Quidel
    Country of Origin: Unknown
    Application: Respiratory Test Kit
    CLIA Classified: CLIA Waived
    Contents 1: (25) Individually Packaged Test Cassettes, (25) Reagent Tubes, (25) Ampoules of Reagent Solution, (25) Sterile Nasal Swabs, (25) X 120 µL Fixed Volume Pipettes, Flu + SARS Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference
    For Use With: For use with Sofia 2 Fluorescent Immunoassay Analyzer
    Is_ECAT: N
    Is_GSA: Y
    Is_VA: N
    Number of Tests: 25 Tests
    Product Dating: McKesson Acceptable Dating: we will ship >= 60 days
    Purchase Program Type: Standard Purchase
    Reading Type: Machine Read
    Sample Type: Nasal Swab Sample
    Specialty: Immunoassay
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