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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 - 00380740138608

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-15
Not in Commercial Distribution

  • 00380740138608 ()
04P5515

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740007584

ARCHITECT cSystems Assay Disk SI Units version 22.0
ABBOTT LABORATORIES
04J6225
In Commercial Distribution

  • 00380740007584 ()
04J6225

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740161323

ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00
ABBOTT LABORATORIES
8K51-07
In Commercial Distribution

  • 00380740161323 ()
08K5107

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740160807

Alinity i B_hCG Assay File
Abbott GmbH
07P515A
In Commercial Distribution

  • 00380740160807 ()
07P515A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740159429

ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-23
Not in Commercial Distribution

  • 00380740159429 ()
04P5723

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740159412

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-20
Not in Commercial Distribution

  • 00380740159412 ()
04P5520

  • Laboratory instrument/analyser application software IVD

AlinIQ - 00380740158255

AlinIQ AMS
ABBOTT SRL
03R89-21
In Commercial Distribution

  • 00380740158255 ()
03R8921

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740156909

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 - 00380740156893

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 - 00380740156886

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
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