BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmunoCAP Total IgE Control LMH

    DI: 07333066019642 · Model: 10-9447-01 · Phadia AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImmunoCAP Total IgE Control LMH
    Primary DI
    07333066019642
    Version / Model
    10-9447-01
    Catalog Number
    10-9447-01
    Company Name
    Phadia AB
    Labeler DUNS
    354019424
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-26
    Public Version
    1
    Public Version Date
    2019-04-03
    Public Version Status
    New
    Public Device Record Key
    100def06-fe8e-4e79-8ecb-b6cae27f14bb

    Device Description

    Contains two vials of each Total IgE Control (L, M, H) for the ImmunoCAP Total IgE method.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    DGC IGE, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    30506 Plasma protein IVD, control

    Identifiers

    Type ID
    Primary 07333066019642

    Customer Contacts

    Phone
    +469999999999
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K133404 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius