M12014 - Escherichia coli Monovalent O Antiserum - Factor O26 - 2ml


Product Overview

M12014
Mast Assure Escherichia coli O26 antiserum - M12014


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative detection of antigens from multiple strains of Escherichia coli (E. coli) bacteria [e.g., O86: K61, O114: K90, O125: K70, O127: K63, O128: K67, O44: K74, O112: K66, O124: K72, O142: K86] isolated by culture from a clinical specimen, using an agglutination method.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 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: GNA

    Device Name: Antisera, All Types, Escherichia Coli

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: MI

    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: 866.3255

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 15060392376253

    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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