BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alpha-Tec Systems

    DI: 00816085020570 · Model: 0 · Alpha-TEC Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    Alpha-Tec Systems
    Primary DI
    00816085020570
    Version / Model
    0
    Catalog Number
    0003255
    Company Name
    Alpha-TEC Systems, Inc.
    Labeler DUNS
    103105524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2022-08-10
    Public Version
    1
    Public Version Date
    2022-08-18
    Public Version Status
    New
    Public Device Record Key
    444ee615-489b-4583-a03c-37e2310a3a38

    Device Description

    PROTO-FIX QC Slides

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    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
    LDZ Fixative, Alcohol Containing

    GMDN Terms

    Code Name
    43510 Biological stain control IVD

    Identifiers

    Type ID
    Unit of Use 00816085020181
    Primary 00816085020570