13 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Excyte®
FDA UDI
ELITechGroup B.V.·03661540700675·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700064·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700446·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700118·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700613·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700668·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700606·
Selectra
FDA UDI
ELITechGroup B.V.·03661540600401·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700125·
Excyte®
FDA UDI
ELITechGroup B.V.·03661540700071·
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·September 7, 2018
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.
FDA Enforcement
Class III
·Terminated·ELITech Group B.V.·October 9, 2019
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.
FDA Recall
Terminated
·ELITech Group B.V. Van Rensselaerweg 4 Spankeren Netherlands·Product code JJE·July 12, 2016