BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioCode Respiratory Pathogen Panel

    DI: 00851034007073 · Model: 01 · APPLIED BIOCODE, INC.
    View on AccessGUDID
    Product Codes
    10
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioCode Respiratory Pathogen Panel
    Primary DI
    00851034007073
    Version / Model
    01
    Catalog Number
    63-R0001
    Company Name
    APPLIED BIOCODE, INC.
    Labeler DUNS
    004580003
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-10
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    86169df7-c0b5-496c-8036-508b9418e7f5

    Device Description

    In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NSU Instrumentation For Clinical Multiplex Test Systems
    OZZ Bordetella Pertussis Dna Assay System
    OZY Chlamydophila Pneumoniae Dna Assay System
    OZX Mycoplasma Pneumoniae Dna Assay System
    OTG Non-Sars Coronavirus Multiplex Nucleic Acid Assay
    OOU Parainfluenza Multiplex Nucleic Acid Assay
    OEM Human Metapneumovirus (Hmpv) Rna Assay System
    OEP Influenza A Virus Subtype Differentiation Nucleic Acid Assay
    OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
    OCC Respiratory Virus Panel Nucleic Acid Assay System

    GMDN Terms

    Code Name
    61317 Multiple-type respiratory pathogen nucleic acid IVD, control

    Identifiers

    Type ID
    Primary 00851034007073

    Customer Contacts

    Phone
    8332462633
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192485 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -30 – -10 Degrees Celsius