• Home
Share
Print

QuickVue SARS Antigen Test Kit CLIA Waived 25/Bx

1396640 QuidelOrtho Sales Company - 20387
Unit Of Measure

Price

Green Info

This item can only be sold to licensed practitioner or any other person(s) or entity licensed by the State.

Green Info

This item is a professional use item. If your State License number is on file, we can ship this item to you. Otherwise, please include your State License number in the comments section of the order.

Green Info

STOP! First time purchases of this EUA item cannot be done via the internet. All attempts will be canceled. To place your initial order, reach out to your sales consultant or call 1-800-772-4346.

Green Info

This product has an Emergency Use Authorization (EUA) from the FDA. See attached documents: Emergency Use Authorization Letter, Instruction for Use, Healthcare Provider and Patient Fact Sheets.

Green Info

This item is non-returnable.

Green Info

This item requires a CLIA License to purchase this product.

Description

minimizeexpand
QuickVue SARS Antigen Test Kit CLIA Waived 25/Box
  • • This Test Has Not Been FDA Cleared Or Approved, But Has Been Authorized By FDA Under An EUA For Use By Authorized Laboratories.
  • • 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. 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 Po int of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
  • • This product has been authorized only for the detection of proteins from SARS-C
    • Category
    Respiratory
    UNSPSC Taxonomy
    41116100- MANUAL TEST KITS AND QUALITY CONTROLS AND CALIBRATORS AND STANDARDS

    Item

    Test Kit

    Item Type

    SARS Antigen

    Brand

    QuickVue

    With

    Nasal Swabs

    CLIA Classification

    CLIA Waived