HA1C_E HIGH VOLUME CONVERSION KIT ATELLICA CH


Product Overview

HA1C_E HIGH VOLUME CONVERSION KIT ATELLICA CH
ATELLICA HA1C_E HIGH VOLUME CONVERSION KIT - 11470732


Device Description

A device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable device.


Environmental Conditions

  • Special Storage Condition, Specify
    • without restriction

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JJE

    Device Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    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: 862.2160

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00630414306179

    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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