CAPILLARYS 3 URINE KIT IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K192095


Product Overview

CAPILLARYS 3 URINE KIT IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K192095
CAPI 3 URINE - 2513


Device Description

A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.


Environmental Conditions

  • Special Storage Condition, Specify
    • THIS WAY UP FRAGILE HANDLE WITH CARE KEEP DRY
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CEF

    Device Name: Electrophoretic, Protein Fractionation

    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: 862.1630

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 03607360025130

    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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