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    Xpert GBS

    FDA UDI
    CEPHEID·07332940000127·Xpert GBS kit; 10 test kit

    Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Xpert GBS LB

    FDA UDI
    CEPHEID·07332940000882·Xpert GBS LB kit; 10 test kit

    Xpert GBS LB

    FDA UDI
    CEPHEID·07332940000806·Xpert GBS LB kit; 120 test kit

    Revogene GBS LB

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733102363·The Revogene GBS LB assay performed on the Revo...

    Inocu Swabs

    FDA UDI
    MICROBIOLOGICS INC.·10634853001265·Group B Strep Positive

    Inocu Swabs

    FDA UDI
    MICROBIOLOGICS INC.·10634853001272·Group B Strep Negative

    EasyNAT GBS Assay

    Device
    EU IVDR · Eu Ivd Class C ·Ustar Biotechnologies (Hangzhou) Ltd.·On the market·2 countries

    GBS Screen Broth

    Device
    EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·On the market

    GBS Screen Broth

    Device
    EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·On the market

    BIOSYNEX AMPLIFLASH GBS

    Device
    EU IVDR · Eu Ivd Class C ·BIOSYNEX·No longer on the market·1 country

    AmpliVue

    FDA UDI
    QUIDEL CORPORATION·30014613312024·AmpliVue GBS Assay

    GenomEra GBS Assay Kit

    Device
    EU IVDD · Eu Ivd General ·Uniogen Oy·On the market

    GenomEra GBS Assay Kit

    Device
    EU IVDD · Eu Ivd General ·Uniogen Oy·On the market

    BD MAX™ GBS

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382904417727·BD MAX™ GBS

    NeuMoDxTM GBS Test Strip

    FDA UDI
    Neumodx Molecular, Inc.·10814278020045·NeuMoDx GBS Test Strip

    Acrometrix GBS Positive Control

    FDA UDI
    Microgenics Corporation·00884883006386·

    Simplexa™ GBS Direct

    FDA UDI
    DIASORIN MOLECULAR LLC·20816101025644·

    GenePOC™ GBS LB

    FDA UDI
    GenePoc Inc·00628055344018·The GenePOC™ GBS LB assay performed on the revo...

    ARIES® GBS Assay

    FDA UDI
    LUMINEX CORPORATION·00840487100165·The ARIES® GBS Assay is a real-time polymerase ...