Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T


Product Overview

Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH
Atellica CH A1c_E - 11097536


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen, using a spectrophotometry method.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store Upright, Protect from Light, Do not freeze.
  • 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: LCP

    Device Name: Assay, Glycosylated Hemoglobin

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HE

    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: 864.7470

    Third Party Flag: N

    Medical Specialty: HE


    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: 00630414220505

    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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