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    K Number
    K153150
    Device Name
    AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
    Manufacturer
    Inova Diagnostics, Inc.
    Date Cleared
    2015-11-24

    (22 days)

    Product Code
    PIV
    Regulation Number
    866.4750
    Why did this record match?
    Product Code :

    PIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
    Device Description
    NOVA View is an automated fluorescence microscope that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides. The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction. AUTOLoader hardware components consist of a NOVA View alignment base, 3-position stack base, 3 slide carrier stacks (labelled as "Pending", "Completed", "and "Error"), telescoping arm with rotary gripper, and a 2D barcode scanner station. The AUTOLoader can be connected to up to two NOVA View devices.
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    K Number
    DEN140039
    Device Name
    NOVA View Automated Fluorescense Microscope
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2015-04-09

    (115 days)

    Product Code
    PIV, AUT
    Regulation Number
    866.4750
    Why did this record match?
    Product Code :

    PIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.
    Device Description
    NOVA View® is an automated fluorescence microscope. The instrument does not process samples. The instrument acquires digital images of representative areas of indirect immunofluorescent slides. Hardware components: - PC and monitor - Keyboard and mouse ● - Microscope - Microscope control unit - Slide stage - LED illumination units - Handheld LED display unit ● - Camera ● - Two fans ● - Printer (optional) ● - UPS (optional) or surge protector - Handheld barcode scanner (optional) ●
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