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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 c Iron Assay File
Abbott GmbH
08P391B
In Commercial Distribution

  • 00380740160791 ()
08P391B

  • Laboratory instrument/analyser application software IVD
Alinity c MagnesiumU Assay File
Abbott GmbH
08P193B
In Commercial Distribution

  • 00380740160784 ()
08P193B

  • Laboratory instrument/analyser application software IVD
Alinity c Magnesium Assay File
Abbott GmbH
08P191B
In Commercial Distribution

  • 00380740160777 ()
08P191B

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-23
Not in Commercial Distribution

  • 00380740159429 ()
04P5723

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-20
Not in Commercial Distribution

  • 00380740159412 ()
04P5520

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R89-21
In Commercial Distribution

  • 00380740158255 ()
03R8921

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000sr System e-Assay CD ROM
ABBOTT LABORATORIES
4P57-22
Not in Commercial Distribution

  • 00380740157067 ()
04P5722

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-19
Not in Commercial Distribution

  • 00380740157050 ()
04P5519

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P06-3A
In Commercial Distribution

  • 00380740156909 ()
05P063A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P06-1A
In Commercial Distribution

  • 00380740156893 ()
05P061A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P08-3A
In Commercial Distribution

  • 00380740156886 ()
05P083A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0
ABBOTT LABORATORIES
5P08-1A
In Commercial Distribution

  • 00380740156879 ()
05P081A

  • Laboratory instrument/analyser application software IVD
Alinity c SerBENZSQ Assay File
Abbott GmbH
09P531A
In Commercial Distribution

  • 00380740155865 ()
09P531A

  • Laboratory instrument/analyser application software IVD
Alinity i tHCY-DIL Assay File
Abbott GmbH
09P283A
In Commercial Distribution

  • 00380740155797 ()
09P283A

  • Laboratory instrument/analyser application software IVD
Alinity i AFP Assay File
Abbott GmbH
07P901B
In Commercial Distribution

  • 00380740154455 ()
07P901B

  • Laboratory instrument/analyser application software IVD
Alinity i HAV-IgM US Assay File
Abbott GmbH
08P281A
In Commercial Distribution

  • 00380740154448 ()
08P281A

  • Laboratory instrument/analyser application software IVD
Alinity i HAV-IgG US Assay File
Abbott GmbH
08P271A
In Commercial Distribution

  • 00380740154431 ()
08P271A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu %N Assay File
Abbott GmbH
08P117A
In Commercial Distribution

  • 00380740154424 ()
08P117A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu C2 Assay File
Abbott GmbH
08P118A
In Commercial Distribution

  • 00380740154417 ()
08P118A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgQu C1 Assay File
Abbott GmbH
08P119A
In Commercial Distribution

  • 00380740154400 ()
08P119A

  • Laboratory instrument/analyser application software IVD
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