BEUDAMED
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    Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    FDA Enforcement
    Class III ·Terminated·Clinical Diagnostic Solutions·November 14, 2012

    Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    FDA Enforcement
    Class III ·Terminated·Clinical Diagnostic Solutions·November 14, 2012

    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    FDA Enforcement
    Class III ·Terminated·Clinical Diagnostic Solutions·November 14, 2012

    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    FDA Enforcement
    Class III ·Terminated·Clinical Diagnostic Solutions·November 14, 2012

    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    FDA Enforcement
    Class III ·Terminated·Clinical Diagnostic Solutions·November 14, 2012

    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019

    Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019

    Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019

    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019

    Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    FDA Enforcement
    Class II ·Terminated·Clinical Diagnostic Solutions·April 16, 2014

    Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018

    BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 3, 2019

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    FDA Enforcement
    Class II ·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020

    Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018

    Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018

    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·October 16, 2024

    Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018

    Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018

    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018

    Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018