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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Architect c8000 CRP1 eAssay CD-ROM
ABBOTT LABORATORIES
6K26-1A
In Commercial Distribution

  • 00380740169978 ()
06K261A

  • 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
ARCHITECT i1000SR System e-Assay CD-ROM - US
ABBOTT LABORATORIES
04P5724
In Commercial Distribution

  • 00380740166465 ()
04P5724

  • Laboratory instrument/analyser application software IVD
ARCHITECT iSystem e-Assay CD-ROM
ABBOTT LABORATORIES
04P5521
Not in Commercial Distribution

  • 00380740166458 ()
04P5521

  • Laboratory instrument/analyser application software IVD
Alinity c Lithium Assay File
Abbott GmbH
08P531B
In Commercial Distribution

  • 00380740166441 ()
08P531B

  • Laboratory instrument/analyser application software IVD
Alinity s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg Confirmatory e-Assay File
Abbott GmbH
06P035A
In Commercial Distribution

  • 00380740162931 ()
06P035A

  • Laboratory instrument/analyser application software IVD
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