This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagnostic use only.


Product Overview

This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagnostic use only.
POINTE SCIENTIFIC AMMONIA - A7553-85


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen, using an enzyme spectrophotometry 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: JIF

    Device Name: Enzymatic Method, Ammonia

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 862.1065

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00811727010254

    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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