BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PD-L1 IHC 22C3 pharmDx

    DI: 05700573003563 · Model: GE006 · AGILENT TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PD-L1 IHC 22C3 pharmDx
    Primary DI
    05700573003563
    Version / Model
    GE006
    Company Name
    AGILENT TECHNOLOGIES, INC.
    Labeler DUNS
    084963177
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-16
    Public Version
    2
    Public Version Date
    2020-12-07
    Public Version Status
    Update
    Public Device Record Key
    d825e5ae-5ef2-4c3f-ba89-f023558779bd

    Device Description

    PD-L1 IHC 22C3 pharmDx

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    GMDN Terms

    Code Name
    61934 Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary 05700573003563

    Premarket Submissions

    Submission Number Supplement Number
    P150013 000
    P150013 001
    P150013 002
    P150013 003
    P150013 004
    P150013 005
    P150013 006
    P150013 007
    P150013 008
    P150013 009
    P150013 010
    P150013 011
    P150013 012
    P150013 013
    P150013 014
    P150013 015
    P150013 016
    P150013 017
    P150013 018

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 60 tests

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius