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Accula Sars-CoV-2 High Positive/Low Positive/Negative Control Kit 9/Box

1417907 Mesa Biotech, Inc - COV4100-1

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Discontinued

Price

$ 90.99
Green Info

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

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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.

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

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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.

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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.

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

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This item requires a CLIA License to purchase this product.

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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.

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This item is non-returnable.

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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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Accula Sars-CoV-2 High Positive/Low Positive/Negative Control Kit 9 Controls, 3 Sets of Controls (High Positive, Low Positive, Negative) 9/Box
BX
  • • This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
  • • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • • The emergency use of this test 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 Act, 21 U.S.C. � 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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


    105BS37_US_MSDS_01.pdf
    105BS37_US_MSDS_01.pdf
    PDF
    105BS37_US_MSDS_01.pdf

    Item

    Control Kit

    Item Type

    Sars-CoV-2

    Brand

    Accula

    Quantity

    9/Box

    Additional Attributes

    9 Controls, 3 Sets of Controls (High Positive, Low Positive, Negative)

    Level

    High Positive/Low Positive/Negative