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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Leica Biosystems CytoVision FISH Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001FLX001
Not in Commercial Distribution

  • 00849832004387 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Z-stack software license
Leica Biosystems Richmond, Inc.
23SWR000ZSX001
In Commercial Distribution

  • 00849832004370 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision MFISH Software License
Leica Biosystems Richmond, Inc.
23SWR000MFX001
Not in Commercial Distribution

  • 00849832004363 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping Software Update
Leica Biosystems Richmond, Inc.
23SWR002KLX001
Not in Commercial Distribution

  • 00849832003793 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Spot Counting Software
Leica Biosystems Richmond, Inc.
23SWRSPOTXX001
Not in Commercial Distribution

  • 00849832003724 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001KLX001
Not in Commercial Distribution

  • 00849832003670 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution

  • 07333066001012 ()
12-3801-11

  • Laboratory instrument/analyser application software IVD
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution

  • 10888234002475 ()


  • Laboratory instrument/analyser application software IVD
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution

  • 03610522136421 ()
12010902

  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A54762
In Commercial Distribution

  • 10190302018135 ()


  • Laboratory instrument/analyser application software IVD
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