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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 - 00380740214371

Alinity c TCASQ1 Assay File
Abbott GmbH
09P915A
In Commercial Distribution

  • 00380740214371 ()
09P915A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740213978

Alinity c TBili2 Assay File
Abbott GmbH
04U051B
In Commercial Distribution

  • 00380740213978 ()
04U051B

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213862

ARCHITECT i1000SR System e-Assay CD-ROM-US Version 29.0
ABBOTT LABORATORIES
04P5729
In Commercial Distribution

  • 00380740213862 ()
04P5729

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213855

ARCHITECT i1000SR System e-Assay CD-ROM-US Version 28.0
ABBOTT LABORATORIES
04P5728
In Commercial Distribution

  • 00380740213855 ()
04P5728

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213848

ARCHITECT cSystems Assay Disk SI Units version 21.0
ABBOTT LABORATORIES
04J6224
In Commercial Distribution

  • 00380740213848 ()
04J6224

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213831

ARCHITECT cSystems Assay Disk Conventional Units version 21.0
ABBOTT LABORATORIES
08G9824
In Commercial Distribution

  • 00380740213831 ()
08G9824

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213503

ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM – US Version 5.0
ABBOTT LABORATORIES
06R8905
In Commercial Distribution

  • 00380740213503 ()
06R8905

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740213084

Alinity c ALT2F Assay File
Abbott GmbH
04T843B
In Commercial Distribution

  • 00380740213084 ()
04T843B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740213077

Alinity c ALT2 Assay File
Abbott GmbH
04T841B
In Commercial Distribution

  • 00380740213077 ()
04T841B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740212827

Alinity c Crea2 Urine Assay File
Abbott GmbH
04T913B
In Commercial Distribution

  • 00380740212827 ()
04T913B

  • Laboratory instrument/analyser application software IVD
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