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Respiratory Test Kit QuickVue Professional Use SARS Antigen 25 Tests CLIA Waived

QUI 20387
COVID ANTIGEN TEST DIPSTICK QUICKVUE
UOM : BX (25 EA)
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QuickVue Professional Use
QUI 20387

About this product

Item #: 20387

BX/25


Highlights

COVID ANTIGEN TEST DIPSTICK QUICKVUE

  • For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Testing 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 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
  • Product ships with minimum 60 days dating
  • Please see attached letter for detailed information on a 1 year extension on expiration dating
  • The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms
  • The QuickVue SARS Antigen test does not differentiate between SARS-CoV and SARS-CoV-2
  • 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 results to the appropriate public health authorities
  • Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed; 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 c

Item Specifications

  • Respiratory Test Kit
  • QuickVue Professional Use
  • CLIA Waived
  • (25) Individually Packaged Test Strips, (25) Reagent Tubes, (25) Vials of Reagent Solution with 340 æL Salt Solution, (25) Sterile Nasal Swabs, SARS Positive Control Swab, Negative Control Swab, Package Insert, and Procedure Card
  • United States
  • N
  • Y
  • N
  • Quidel
  • 20387
  • 25 Tests
  • Standard Purchase
  • Visual Read
  • Nasal Swab Sample
  • Immunoassay
  • Test Strip Format
  • Rapid
  • Lateral Flow Method
  • SARS Antigen
  • 10 Minute Results
  • 41116144