121 results
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58ms
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Sources: EU EUDAMED, US FDA
Data Innovations LLC
Manufacturer
🇺🇸 United States
DATA INNOVATIONS, LLC
FDA registration
DATA INNOVATIONS, LLC·3 products·🇺🇸 United States
Bloodstream Software
FDA UDI
DATA INNOVATIONS LLC·B180BSB01110·Bloodstream Software is a standalone software a...
Bloodstream Software
FDA UDI
DATA INNOVATIONS LLC·B180BSB01120·Bloodstream Software is a standalone software a...
Bloodstream Software
FDA UDI
DATA INNOVATIONS LLC·B180BSB01100·Bloodstream Software is a standalone software a...
Instrument Manager
FDA UDI
DATA INNOVATIONS LLC·B180IMB028150·Instrument Manager is a stand-alone software ap...
Instrument Manager
FDA UDI
DATA INNOVATIONS LLC·B180IMB028140·Instrument Manager is a stand-alone software ap...
Instrument Manager
FDA UDI
DATA INNOVATIONS LLC·B180IMB028160·Instrument Manager is a stand-alone software ap...
Instrument Manager
FDA UDI
DATA INNOVATIONS LLC·B180IMB029000·Instrument Manager is a stand-alone software ap...
Instrument Manager
FDA UDI
DATA INNOVATIONS LLC·B180IMB028170·Instrument Manager is a stand-alone software ap...
Instrument Manager
FDA UDI
DATA INNOVATIONS LLC·B180IMB029010·Instrument Manager is a stand-alone software ap...
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code MMH·February 11, 2026
INSTRUMENT MANAGER
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code JQP·September 13, 2024
JRESULTNET USING PROVUE DRIVER V1.5.3 OR LOWER
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code JQP·August 22, 2014
SEBIA PHORESIS
FDA Adverse Event
Malfunction
·SEBIA INC.·Product code JJN·October 21, 2016
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code JQP·October 25, 2024
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code JQP·April 4, 2025
INSTRUMENT MANAGER
FDA Adverse Event
Malfunction
·DATA INNOVATIONS, LLC·Product code OUG·December 2, 2022
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 11, 2014
INSTRUMENT MANAGER
FDA Adverse Event
Other
·DATA INNOVATIONS LLC·Product code JQP·December 12, 2016