BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NeuMoDx CT/NG Assay 2.0

    K Number: K230267 · Decision Dec 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    325

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NeuMoDx CT/NG Assay 2.0
    K Number
    K230267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3393
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neumodx Molecular, Inc.
    Date Received
    January 31, 2023
    Decision Date
    December 22, 2023
    Product Code
    QEP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QEP), ordered by most recent decision date.

    cobas liat CT/NG nucleic acid test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas liat CT/NG/MG nucleic acid test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Visby Medical Men's Sexual Health Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD CTGCTV2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas® liat CT/NG nucleic acid test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas® liat CT/NG/MG nucleic acid test

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Neumodx Molecular, Inc.

    K Number Device Name
    K173725 NeuMoDx GBS Assay