BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MDx-Chex for BC-GN

    DI: 00844509002437 · Model: 250080 · STRECK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MDx-Chex for BC-GN
    Primary DI
    00844509002437
    Version / Model
    250080
    Catalog Number
    250080
    Company Name
    STRECK, INC.
    Labeler DUNS
    072915986
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-09
    Public Version
    1
    Public Version Date
    2023-08-17
    Public Version Status
    New
    Public Device Record Key
    96cb8b17-4b32-4ab9-a717-244287c6165a

    Device Description

    MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteus spp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

    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
    PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

    GMDN Terms

    Code Name
    61314 Multiple-type bloodstream pathogen nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00844509002437