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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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ARCHITECT i100SR System e-Assay CD-ROM-US Version 27.0
ABBOTT LABORATORIES
04P5727
In Commercial Distribution

  • 00380740211431 ()
04P5727

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 26.0
ABBOTT LABORATORIES
04P5526
In Commercial Distribution

  • 00380740211424 ()
04P5526

  • Laboratory instrument/analyser application software IVD
Alinity c IgE-US Assay File
Abbott GmbH
01R133A
In Commercial Distribution

  • 00380740209544 ()
01R133A

  • Laboratory instrument/analyser application software IVD
Alinity i STAT High Sensitivity Troponin-I
Abbott GmbH
04Z211B
In Commercial Distribution

  • 00380740209438 ()
04Z211B

  • Laboratory instrument/analyser application software IVD
Alinity i UCH-L1 Assay File
Abbott GmbH
04W191B
In Commercial Distribution

  • 00380740208936 ()
04W191B

  • Laboratory instrument/analyser application software IVD
Alinity i GFAP Assay File
Abbott GmbH
04W171B
In Commercial Distribution

  • 00380740208929 ()
04W171B

  • Laboratory instrument/analyser application software IVD
Alinity i TBI Assay File
Abbott GmbH
04Z231B
In Commercial Distribution

  • 00380740208912 ()
04Z231B

  • Laboratory instrument/analyser application software IVD
Alinity c %A1cWB Assay File
Abbott GmbH
08P435D
In Commercial Distribution

  • 00380740204112 ()
08P435D

  • Laboratory instrument/analyser application software IVD
Alinity c A1cWB Assay File
Abbott GmbH
08P433D
In Commercial Distribution

  • 00380740204105 ()
08P433D

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 25.0
ABBOTT LABORATORIES
04P5525
In Commercial Distribution

  • 00380740204082 ()
04P5525

  • Laboratory instrument/analyser application software IVD
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