BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Acuitas

    DI: 01812125010074 · Model: AC043 · Opgen, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acuitas
    Primary DI
    01812125010074
    Version / Model
    AC043
    Catalog Number
    AC043
    Company Name
    Opgen, Inc.
    Labeler DUNS
    119234263
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-25
    Public Version
    3
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    8f440cd6-32ff-4710-8727-a9090411c8e4
    Distribution End Date
    2022-03-25

    Device Description

    QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
    JJH Clinical Sample Concentrator

    GMDN Terms

    Code Name
    57871 Specimen processing instrument IVD

    Identifiers

    Type ID
    Primary 01812125010074

    Customer Contacts

    Phone
    301-869-9683
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K191288 000