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510(k) Data Aggregation

    K Number
    K113135
    Device Name
    UNISTRIP 1
    Manufacturer
    UNISTRIP TECHNOLOGIES, LLC
    Date Cleared
    2013-11-06

    (744 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNISTRIP TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unistrip1™ Test Strips are used with the OneTouch "Ultra", OneTouch" Ultra2", OneTouch" UltraMini and One-Touch UltraSmart meters purchased before October 2012, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The Unistrip1™ is meant for self-testing of blood . glucose as an aid to monitor the effectiveness of diabetes control. They are for single patient use only and should not be shared. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. UniStrip1™ Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch Ultra meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly). Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
    Device Description
    The UniStrip1™ Test Strips are used with the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and QneTouch® UltraSmart® blood glucose monitoring systems. The UniStrip1™ test Strips is intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1™ Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch Ultra meter). The UniStrip1™ Test Strip can only be used on the OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before October 2012. UniStrip1™ Test Strips are only for use with calibration code 49.
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