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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ARCHITECT i System e-Assay CD-ROM-US Version 23.0
ABBOTT LABORATORIES
04P5523
In Commercial Distribution

  • 00380740192754 ()
04P5523

  • Laboratory instrument/analyser application software IVD
Alinity c Uric2-U Assay File
Abbott GmbH
04U093A
In Commercial Distribution

  • 00380740192723 ()
04U093A

  • Laboratory instrument/analyser application software IVD
Alinity i COV-2 IgM Assay File
Abbott GmbH
06R911A
In Commercial Distribution

  • 00380740192464 ()
06R911A

  • Laboratory instrument/analyser application software IVD
Alinity i COV-2 IgG Assay File
Abbott GmbH
06R901A
In Commercial Distribution

  • 00380740192457 ()
06R901A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM - US Version 2.0
ABBOTT LABORATORIES
06R8902
Not in Commercial Distribution

  • 00380740192426 ()
06R8902

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM - US
ABBOTT LABORATORIES
04P5522
In Commercial Distribution

  • 00380740192372 ()
04P5522

  • Laboratory instrument/analyser application software IVD
Architect cSystem e-Assay CD-ROM SI-Units/Alternate Units
ABBOTT LABORATORIES
4J62-19
In Commercial Distribution

  • 00380740169848 ()
04J6219

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem eAssay CD-ROM Conventional Units/Alternate Units
ABBOTT LABORATORIES
8G98-19
In Commercial Distribution

  • 00380740169831 ()
08G9819

  • Laboratory instrument/analyser application software IVD
ARCHITECT MULTIGENT e-ASSAY CD-ROM SI Units / Alternate Units
ABBOTT LABORATORIES
8K51-08
In Commercial Distribution

  • 00380740169046 ()
08K5108

  • Laboratory instrument/analyser application software IVD
ARCHITECT MULTIGENT e-ASSAY CD-ROM Conventional Units / Alternate Units
ABBOTT LABORATORIES
8K50-08
In Commercial Distribution

  • 00380740169039 ()
08K5008

  • Laboratory instrument/analyser application software IVD
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