17 results
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50ms
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Sources: EU EUDAMED, US FDA
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
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 Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 16, 2019
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
FDA Enforcement
Class II
·Ongoing·Vital Scientific N.V.·December 4, 2019
V-Twin, Model # 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 Enforcement
Class II
·Ongoing·Vital Scientific N.V.·October 2, 2019
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012
V-Twin, Model # 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
Open, Classified
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 18, 2016
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JGS·January 10, 2012
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012
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
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JGS·January 10, 2012
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Recall
Terminated
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·January 10, 2012
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
FDA Recall
Open, Classified
·Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands·Product code JJF·November 15, 2018
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