23 results
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19ms
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Sources: EU EUDAMED, US FDA
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
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
Atellica CH 930 Analyzer (SMN 11067000) . 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 Prime (SMN 11069001). 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
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
FDA Enforcement
Class II
·Terminated·Alfa Wassermann, Inc.·February 6, 2013
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
FDA Enforcement
Class II
·Terminated·Quidel Corporation·August 9, 2017
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·August 7, 2013
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·February 5, 2014