Devices & Diagnostics > Device

The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).


by ARKRAY USA, INC.
Product Overview

The ADAMS A1c HA
ADAMS™ A1c HA-8180V (UL) Analyzer - 100675


Device Description

A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).


Environmental Conditions

  • Special Storage Condition, Specify
    • Environment during transit (1-60 Degrees Celsius and 20-80% RH)
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 1.00


    • 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: 04987486001973

    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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