Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500


Product Overview

Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
eIHC IVD bundle AT Turbo-2500 - 23ATTIVD-2500


Device Description

An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.


Environmental Conditions


Device Sizes


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NQN

    Device Name: Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

    Device Class: 2

    Physical State: N/A

    Definition: Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

    Submission Type ID: 1

    Review Panel: PA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 864.1860

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00815477020068

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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