121 results · 58ms · Sources: EU EUDAMED, US FDA

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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