BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Autostat II Anti-Scl-70

    DI: 00816879020342 · Model: FGA34 · HYCOR BIOMEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Autostat II Anti-Scl-70
    Primary DI
    00816879020342
    Version / Model
    FGA34
    Company Name
    HYCOR BIOMEDICAL LLC
    Labeler DUNS
    010558476
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-26
    Public Version
    5
    Public Version Date
    2024-09-06
    Public Version Status
    Update
    Public Device Record Key
    8f6334df-f7a7-4959-8c64-89fed03e1518
    Distribution End Date
    2023-09-30

    Device Description

    96 well ELISA for the detection of anti-Scl-70 antibodies in human serum

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

    GMDN Terms

    Code Name
    55126 Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00816879020342

    Customer Contacts

    Phone
    800-382-2527
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius