BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FilmArray® BCID Panel

    DI: 00815381020086 · Model: RFIT-ASY-0126 · BIOFIRE DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FilmArray® BCID Panel
    Primary DI
    00815381020086
    Version / Model
    RFIT-ASY-0126
    Catalog Number
    RFIT-ASY-0126
    Company Name
    BIOFIRE DIAGNOSTICS, LLC
    Labeler DUNS
    079280262
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2022-12-22
    Public Version Status
    Update
    Public Device Record Key
    b944bfdd-2aed-429f-bb12-69d86315ec0b
    Distribution End Date
    2022-11-30

    Device Description

    IVD reagent kit containing 30 tests.

    Device Characteristics

    Single Use
    Yes
    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
    OOI Real Time Nucleic Acid Amplification System
    PAM Gram-Positive Bacteria And Their Resistance Markers
    PEN Gram-Negative Bacteria And Associated Resistance Markers

    GMDN Terms

    Code Name
    61308 Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

    Identifiers

    Type ID
    Primary 00815381020086