BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AMPLIVUE GBS ASSAY

    K Number: K133503 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    37
    Review Days
    36

    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
    AMPLIVUE GBS ASSAY
    K Number
    K133503
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corporation
    Date Received
    November 14, 2013
    Decision Date
    December 20, 2013
    Product Code
    NJR
    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
    NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

    Similar 510(k) Clearances

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

    Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Simplexa GBS Direct, Simplexa GBS Positive Control Pack

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Panther Fusion GBS Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NeuMoDx GBS Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Solana GBS Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Quidel Corporation

    K Number Device Name
    K231795 QuickVue COVID-19 Test
    K232286 Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
    K233688 Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
    K230349 Lyra RSV+hMPV Assay
    DEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
    K230236 Lyra Influenza A+B Assay
    K211342 Sofia 2 Campylobacter FIA
    K173496 Sofia 2 Lyme FIA, Sofia Lyme Control Set
    K181029 Solana Bordetella Complete Assay
    K173691 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
    Search all 37 clearances from Quidel Corporation →