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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 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
ARCHITECT i1000SR e-Assay CD-ROM
ABBOTT LABORATORIES
04P5721
Not in Commercial Distribution

  • 00380740153441 ()
04P5721

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
04P5518
Not in Commercial Distribution

  • 00380740153434 ()
04P5518

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD
Alinity c Valproic Assay File
Abbott GmbH
09P921A
In Commercial Distribution

  • 00380740152123 ()
09P921A

  • Laboratory instrument/analyser application software IVD
Alinity c Theo Assay File
Abbott GmbH
09P891A
In Commercial Distribution

  • 00380740152093 ()
09P891A

  • Laboratory instrument/analyser application software IVD
Alinity c RheumF Assay File
Abbott GmbH
04R991A
In Commercial Distribution

  • 00380740152086 ()
04R991A

  • Laboratory instrument/analyser application software IVD
Alinity c Phenobarb Assay File
Abbott GmbH
09P851A
In Commercial Distribution

  • 00380740152055 ()
09P851A

  • Laboratory instrument/analyser application software IVD
Alinity c IgM Assay File
Abbott GmbH
09P631A
In Commercial Distribution

  • 00380740152000 ()
09P631A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-20
Not in Commercial Distribution

  • 00380740150150 ()
04P5720

  • Laboratory instrument/analyser application software IVD
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