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CovAb SARS-CoV-2 Positive/ Negative Control 1/Bx

1408050 Diabetomics, Inc. - 2039

Unit Of Measure
Discontinued

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

This product is a refrigerated product and will be shipped separately. Refrigerated items do not ship on Friday unless prior arrangements are made for Saturday delivery.

Green Info

This is a non-returnable item.

Green Info

This product is no longer available. It is maintained in the catalog so that customers with purchase history can see the descriptions. Please search for a substitute.

Green Info

This product is no longer available. It is maintained in the catalog so that customers with purchase history can see the descriptions. Please search for a substitute.

Green Info

This product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.

Green Info

This product is no longer available. It is maintained in Aruba so that customers with purchase history can see the descriptions. Pleasesearch for a substitute.

Green Info

This product is a control, not the test. This control is to be used with the appropriate Emergeny Use Authorization Test Kit. See attached documents: Emergency Use Authorization letter, Instruction for use, Healthcare Provider and Patient Fact Sheets.

Green Info

This product is no longer available. Please see our suggested substitute, search catalog for alternative item, or contact your sales consultant for assistance.

Description

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CovAb SARS-CoV-2 Positive/ Negative Control 1/Box
  • • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories
  • • Authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care, 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 detecting the presence of total antibodies to SARS-CoV-2, not for any other viruses or pathogens.
  • • This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21

  • Category
    Respiratory
    UNSPSC Taxonomy
    41116100- MANUAL TEST KITS AND QUALITY CONTROLS AND CALIBRATORS AND STANDARDS


    Item

    Control

    Item Type

    SARS-CoV-2

    Brand

    CovAb

    Quantity

    1/Box

    Level

    Positive/ Negative