94 results
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47ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NTI·March 9, 2007
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·January 2, 2013
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012