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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Type Device Class Implantable

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FACS - 00382906577658

BD FACS™ Sample Prep Assistant III Software
Becton, Dickinson And Company
657765
In Commercial Distribution

  • 00382906577658 ()
657765

  • Laboratory instrument/analyser application software IVD

BD FACSCanto™ - 00382906570819

FACSCanto V2.4 SW With Dongle
BECTON, DICKINSON AND COMPANY
657081
Not in Commercial Distribution

  • 00382906570819 ()
657081

  • Laboratory instrument/analyser application software IVD

BD FACSCanto™ - 00382906466037

BD FACSCanto System II Upgrade V2.4
BECTON, DICKINSON AND COMPANY
646603
Not in Commercial Distribution

  • 00382906466037 ()
646603

  • Laboratory instrument/analyser application software IVD

BD FACSCanto™ - 00382906466020

BD FACSCanto System Upgrade V2.4
BECTON, DICKINSON AND COMPANY
646602
Not in Commercial Distribution

  • 00382906466020 ()
646602

  • Laboratory instrument/analyser application software IVD

BD Multiset™ - 00382906434371

Multiset SW V3.0.2/User Guide Bundle
Becton, Dickinson And Company
643437
In Commercial Distribution

  • 00382906434371 ()
643437

  • Laboratory instrument/analyser application software IVD

N/A - 00382906407764

BD® HLA-B27 Application Module v1.0
BECTON, DICKINSON AND COMPANY
640776
Not in Commercial Distribution

  • 00382906407764 ()
640776

  • Laboratory instrument/analyser application software IVD

BD Synapsys™ Informatics Solution - 00382904441395

BD Synapsys™ Informatics Solution
BECTON, DICKINSON AND COMPANY
444139
In Commercial Distribution

  • 00382904441395 ()
444139

  • Laboratory instrument/analyser application software IVD

EKF Link - 04048534002011

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.
EKF-diagnostic GmbH
0760-0101
In Commercial Distribution

  • 04048534002011 ()
0760-0101

  • Laboratory instrument/analyser application software IVD

Concentriq AP-Dx - 00860006054595

Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.
Proscia Inc.
DX040US
In Commercial Distribution

  • 00860006054595 ()
4.8.1

  • Laboratory instrument/analyser application software IVD

Concentriq AP-Dx-US - 00860006054557

Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
Proscia Inc.
4.6
In Commercial Distribution

  • 00860006054557 ()
US

  • Laboratory instrument/analyser application software IVD
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