BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MRSA/SA ELITe MGB

    DI: 03661540950001 · Model: M800346 · Elitechgroup Mdx LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MRSA/SA ELITe MGB
    Primary DI
    03661540950001
    Version / Model
    M800346
    Company Name
    Elitechgroup Mdx LLC
    Labeler DUNS
    117458512
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-13
    Public Version
    5
    Public Version Date
    2025-12-23
    Public Version Status
    Update
    Public Device Record Key
    b3cdd036-7c3d-47b3-899f-c2adf32ff9d5
    Distribution End Date
    2025-12-22

    Device Description

    MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

    GMDN Terms

    Code Name
    60864 MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 03661540950001

    Customer Contacts

    Phone
    8004532725
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K112937 000