BEUDAMED
    10,000 results · 66ms · Sources: EU EUDAMED, US FDA

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

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Alethia™ Group B Streptococcus External Control Kit

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733102110·The Alethia GBS External Control Kit contains P...

    illumigene Group B Streptococcus External Control Kit

    FDA UDI
    MERIDIAN BIOSCIENCE, INC.·00840733101311·The illumigene GBS External Control Kit contain...

    GBS-Db1031ac

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Baisheng Medical Co., Ltd.·1 device

    Sigma GBS

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Medical Wire & Equipment Co Bath (Ltd)·1 device

    Sigma GBS

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Medical Wire & Equipment Co Bath (Ltd)·1 device

    HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIOSYNEX AMPLIFLASH GBS

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·BIOSYNEX·1 device

    GBS-Dm 1130n

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Baisheng Medical Co., Ltd.·1 device

    GBS-Dm 1130ac

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Baisheng Medical Co., Ltd.·1 device

    Xpert® GBS

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cepheid·1 device

    EasyNAT GBS Assay

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Ustar Biotechnologies (Hangzhou) Ltd.·1 device

    EasyNAT GBS Assay

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Ustar Biotechnologies (Hangzhou) Ltd.·1 device

    NATtrol™ CT/NG/TV External Run Control Kit

    FDA registration
    ZEPTOMETRIX LLC.·1 product·🇺🇸 United States

    Electrosurgical pads GBS-Dm2130c-0802

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Baisheng Medical Co., Ltd.·1 device

    Tigsun GBS Antigen Rapid Test

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

    Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG) HE0045N

    FDA registration
    MICROBIOLOGICS, INC.·1 product·🇺🇸 United States

    Gbs Culture Media, Selective And Differential

    FDA classification
    FDA Class 1 ·Gbs Culture Media, Selective And Differential

    XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Quidel Molecular Parainfluenza Virus Control Set (M115)

    FDA registration
    Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States