Syva® Emit® 2000 Phenytoin Calibrators


Product Overview

Syva® Emit® 2000 Phenytoin Calibrators
Syva® Emit® 2000 Phenytoin Calibrators - 10445304


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug phenytoin (e.g., dilantin) in a clinical specimen.


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: DIP

    Device Name: Enzyme Immunoassay, Diphenylhydantoin

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: TX

    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: 862.3350

    Third Party Flag: Y

    Medical Specialty: TX


    Device Identifiers

    Device Id: 00842768017391

    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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