Devices & Diagnostics > Device

Penicillium brevi-compactum-Specific IgE - IMMULITE - RGT


by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Product Overview

Penicillium brevi
IMMULITE®2000 Systems 3gAllergy™ Penicillium brevi-compactum - 10386030


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 immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.


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: DHB

    Device Name: System, Test, Radioallergosorbent (Rast) Immunological

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5750

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00630414978833

    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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