BEUDAMED
    25 results · 54ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    S.D. Sight Diagnostics Ltd

    Manufacturer
    🇮🇱 Israel·2 Basic UDI-DIs·2 Devices

    OLO CBC Test Kit

    FDA UDI
    S.D. SIGHT DIAGNOSTICS LTD·B787TK10·A disposable cartridge and sample preparation t...

    Sight OLO

    FDA UDI
    S.D. SIGHT DIAGNOSTICS LTD·B787OLOU10·The Sight OLO device is a computer vision based...

    OLO Control Kit

    FDA UDI
    S.D. SIGHT DIAGNOSTICS LTD·B787OCK10·An in vitro diagnostic control reagent designed...

    Sight OLO

    Device
    EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·No longer on the market

    Sight OLO CBC Test Kit

    Device
    EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·No longer on the market

    Sight OLO

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·1 device

    Sight OLO CBC Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·S.D. Sight Diagnostics Ltd·1 device

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Enforcement
    Class II ·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024

    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

    FDA Enforcement
    Class II ·Terminated·SIGHT DIAGNOSTICS LTD·September 29, 2021

    Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

    FDA Enforcement
    Class II ·Ongoing·SIGHT DIAGNOSTICS LTD·August 3, 2022

    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

    FDA Enforcement
    Class II ·Ongoing·SIGHT DIAGNOSTICS LTD·April 27, 2022

    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

    FDA Recall
    Terminated ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·March 17, 2021

    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·January 20, 2022

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·May 13, 2024

    Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·June 14, 2022

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    Caretechion GmbH

    Authorized representative
    🇩🇪 Germany·158 Manufacturers·1463 Devices