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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 Device Size Type Device Class Implantable

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Alinity - 00380740138899

Alinity i TSH Assay File
Abbott GmbH
07P481A
In Commercial Distribution

  • 00380740138899 ()
07P481A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740138615

ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-18
Not in Commercial Distribution

  • 00380740138615 ()
04P5718

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740138608

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-15
Not in Commercial Distribution

  • 00380740138608 ()
04P5515

  • Laboratory instrument/analyser application software IVD

BD FACSuite - 00382906657329

BD FACSuite™ Clinical BD Leucocount™ Assay Module
Becton, Dickinson And Company
665732
In Commercial Distribution

  • 00382906657329 ()
665732

  • Laboratory instrument/analyser application software IVD

BD FACSDiva - 00382906643452

BD FACSDiva™ v9.0.1
Becton, Dickinson And Company
664345
In Commercial Distribution

  • 00382906643452 ()
664345

  • Laboratory instrument/analyser application software IVD

FACSuite - 00382906642370

BD FACSuite™ Clinical, BD Multitest™ 6-Color Assays
Becton, Dickinson And Company
664237
In Commercial Distribution

  • 00382906642370 ()
664237

  • Laboratory instrument/analyser application software IVD

FACSuite - 00382906642363

BD FACSuite™ Clinical, BD Multitest™ 4-Color Assays
Becton, Dickinson And Company
664236
In Commercial Distribution

  • 00382906642363 ()
664236

  • Laboratory instrument/analyser application software IVD

FACSuite - 00382906642356

BD FACSuite™ Clinical Application
Becton, Dickinson And Company
664235
In Commercial Distribution

  • 00382906642356 ()
664235

  • Laboratory instrument/analyser application software IVD

FACSVia - 00382906605610

BD FACSVia™ Clinical Software, Test Definitions, and Documentation v1.2
Becton, Dickinson And Company
660561
In Commercial Distribution

  • 00382906605610 ()
660561

  • Laboratory instrument/analyser application software IVD

BD FACSCanto™ - 00382906595348

SW FACSCanto II 3.0 no dongle ROW
BECTON, DICKINSON AND COMPANY
659534
Not in Commercial Distribution

  • 00382906595348 ()
659534

  • Laboratory instrument/analyser application software IVD
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