Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert.


Product Overview

Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert.
Afinion HbA1c Dx - 1116482


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 qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 46.00
    • 36.00
  • Handling Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00
  • Special Storage Condition, Specify
    • Do not freeze

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PDJ

    Device Name: Hemoglobin A1c Test System

    Device Class: 2

    Physical State: In-Vitro Diagnostic Reagent Kit

    Definition: Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

    Submission Type ID: 1

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Assay detecting glycated hemoglobin

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Whole blood

    Regulation Number: 862.1373

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 07070060012889

    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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