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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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BD FACSCount™ - 00382903446193

BD FACSCount System Users Guide and Software
Becton, Dickinson And Company
344619
In Commercial Distribution

  • 00382903446193 ()
344619

  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Karyotype & FISH Software Update - 00849832003687

Leica Biosystems CytoVision Karyotype & FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002KFL001
Not in Commercial Distribution

  • 00849832003687 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Karyotyping Software License Activation - 00849832003649

Leica Biosystems CytoVision Karyotyping Software License Activation
Leica Biosystems Richmond, Inc.
23SWR000KLX001
Not in Commercial Distribution

  • 00849832003649 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision Karyotyping & FISH Review software - 00849832003632

Leica Biosystems CytoVision Karyotyping & FISH Review software
Leica Biosystems Richmond, Inc.
23SWR000KFX001
Not in Commercial Distribution

  • 00849832003632 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

FACSDiva - 00382906642868

Software Kit FACSDiva 9.4 RUO w/Dongle
BECTON, DICKINSON AND COMPANY
664286
Not in Commercial Distribution

  • 00382906642868 ()
664286

  • Laboratory instrument/analyser application software IVD

ROMA - 00869164000024

ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
Fujirebio Diagnostics, Inc.
404-10US
In Commercial Distribution

  • 00869164000024 ()


  • Laboratory instrument/analyser application software IVD

IH-Com - 03610520569870

IH-Com Kit Fullversion US; Software Version: 04.0.27.
Bio-Rad Medical Diagnostics GmbH
04.0.27
In Commercial Distribution

  • 03610520569870 ()
009100

  • Laboratory instrument/analyser application software IVD

ViroSeq - 00884999039278

ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
ABBOTT MOLECULAR INC.
4J94-23
In Commercial Distribution

  • 00884999039278 ()
4J94-23

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683276

NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD

Acuitas - 20812125010086

Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution

  • 20812125010086 ()
CP3511

  • Laboratory instrument/analyser application software IVD
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