This product is intended for the quantitative in vitro determination of Sodium in serum


Product Overview

This product is intended for the quantitative in vitro determination of Sodium in serum
Na - NA8327


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of sodium (Na+) in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • R1 Stable for 2 weeks at +2 to +8°C or 5 days at +15 to +25°C once opened. R2 Stable for 4 weeks at +2 to +8°C or 2 weeks at +15 to +25°C once opened.
  • 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: CEI

    Device Name: Uranyl Acetate/Zinc Acetate, Sodium

    Device Class: 2

    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: 862.1665

    Third Party Flag: Y

    Medical Specialty: CH


    Device Identifiers

    Device Id: 05055273209310

    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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