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Calculator/Data Processing Module, For Clinical Use

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Company Name
Description
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USB-STICK MAGELLAN 7.3 SP2
Tecan Austria GmbH
This media contains the following registered Medical Devices:(DI) 09120052070996 MAGELLAN V7.X(DI) 09120052071009 MAGELLAN TRACKER V7.X
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MAGELLAN
Tecan Austria GmbH
Reader control and data reduction software for Tecan Microplate Reader.
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MAGELLAN
Tecan Austria GmbH
Reader control and data reduction software for Tecan Microplate Reader.
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USB-STICK MAGELLAN PRO V 7.3
Tecan Austria GmbH
This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
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MAGELLAN PRO
Tecan Austria GmbH
Reader control and data reduction software for Tecan Microplate Reader.
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MAGELLAN PRO
Tecan Austria GmbH
Reader control and data reduction software for Tecan Microplate Reader.
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ProTube
Inpeco SA
ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
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ProTube
Inpeco SA
The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
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cobas® infinity central lab
Roche Diagnostics GmbH
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cobas pro B-Gate update Kit
Roche Diagnostics GmbH
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cobas infinity POC IT solutions
Roche Diagnostics GmbH
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cobas infinity POC remote access
Roche Diagnostics GmbH
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BCM for cobas 8100
Roche Diagnostics GmbH
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N/A
STRYKER CORPORATION
QBL Software License
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SURGICOUNT
STRYKER CORPORATION
+ EMR/QBL APPLICATION
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HemoCue® 801 Connect
Hemocue AB
HemoCue® 801 Connect
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Eonis Analysis software
Wallac Oy
The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
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EVOYA Platform
Wallac Oy
The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals.The Evoya Software Platform is intended for in vitro diagnostic use.
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MSMS Workstation
Wallac Oy
The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
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Screening Center
Wallac Oy
Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
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Specimen Gate Laboratory
Wallac Oy
Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
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PatientCare
Wallac Oy
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
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Bench Lab CNV
Agilent Technologies Belgium
Bench LAB CNV
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Alissa Interpret
Agilent Technologies Belgium
Alissa Interpret
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wtATTR-CM AcceleraTTR™
PFIZER INC.
Software to identify heart failure patients who may be at risk of having wtATTR-CM
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EKF Link
EKF-diagnostic GmbH
EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.EKF Link facilitates the setting of configurable options of connected analyzers.
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B-Gate Interface
Roche Diagnostics GmbH
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cobas&#x00AE infinity central lab
Roche Diagnostics GmbH
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cobas p 701 Post-Analytical Unit
Roche Diagnostics GmbH
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cobas p 501 post-analytical unit
Roche Diagnostics GmbH
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cobas IT 1000
Roche Diagnostics GmbH
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TDBactiLink
TECHNIDATA
TDBactiLink is a middleware for paperless bacteriology - Designed with bacteriologists, TDBactiLink is a tailored response to the specific needs of this fast-changing discipline.
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TD-Web
TECHNIDATA
TD-Web is a web solution to easily manage orders creation, optimize collection management and provide real-time results access at the patient’s bedside.
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TDWorkstation
TECHNIDATA
TDWorkstation is a powerful software designed to interface instruments with any Laboratory Information System (LIS) and manage results with efficiency and flexibility.
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TDGenet
TECHNIDATA
Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.
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TDHisto/Cyto
TECHNIDATA
TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities..
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TDNexLabs
TECHNIDATA
TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information.TDNexLabs is intended to be used only by health professionals.
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STA Coag Expert®
DIAGNOSTICA STAGO
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Coag.One server license
DIAGNOSTICA STAGO
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Coag.One server license
DIAGNOSTICA STAGO
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STA Coag Expert®
DIAGNOSTICA STAGO
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Rightest
BIONIME CORPORATION
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GE
BIONIME CORPORATION
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Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology
MEDICAL INFORMATION TECHNOLOGY, INC.
MEDITECH's Laboratory application closely integrates requisition, specimen processing, and patient information with data in Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry through seamless integration with laboratory instruments. Authorized users have the ability to view laboratory results via a specimen inquiry or a patient summary. MEDITECH's Genetics application closely integrates requisition, specimen processing, and patient information with data in an Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry. Authorized users have the ability to view genetic test results via a specimen inquiry or a patient summary.MEDITECH's Microbiology application closely integrates requisition, specimen processing, and patient information with data in the Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient processing for collection and resulting of specimens including: bacteriology, mycology, parasitology, virology, and mycobacteriology. MEDITECH's Anatomical Pathology application automates the data handling needs of the Pathology department with features for recording, storing, coding, searching, and reporting Pathology cases. MEDITECH's EHR gives users the ability to view Radiology reports and lab results pertinent to the case, and to integrate relevant data into Pathology reports. Authorized users have the ability to view Anatomic Pathology results from within the network.
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BG Analytics Software
ASSOCIATES OF CAPE COD, INC.
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
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Telserve® Data Management System
TELCARE, LLC
The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management.
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TRITON
GAUSS SURGICAL, INC
Triton QBL
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SoftMolecular
SCC SOFT COMPUTER
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SoftHLA
SCC SOFT COMPUTER
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SoftFlowCytometry
SCC SOFT COMPUTER