BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CRYOcheck Lupus Negative Control

    DI: 00843876000541 · Model: CCLN-05 · Precision Biologic Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    CRYOcheck Lupus Negative Control
    Primary DI
    00843876000541
    Version / Model
    CCLN-05
    Catalog Number
    CCLN-05
    Company Name
    Precision Biologic Inc
    Labeler DUNS
    244713368
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2020-03-06
    Public Version
    1
    Public Version Date
    2020-03-16
    Public Version Status
    New
    Public Device Record Key
    bede0ef6-ca31-4768-aa18-604936bb73f3

    Device Description

    Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    GGN Plasma, Coagulation Control

    GMDN Terms

    Code Name
    46029 Lupus anticoagulant marker IVD, control

    Identifiers

    Type ID
    Primary 00843876000541
    Unit of Use 00843876010540