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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 - 00380740156879

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 - 00380740155797

Alinity i tHCY-DIL Assay File
Abbott GmbH
09P283A
In Commercial Distribution

  • 00380740155797 ()
09P283A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740154455

Alinity i AFP Assay File
Abbott GmbH
07P901B
In Commercial Distribution

  • 00380740154455 ()
07P901B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740154448

Alinity i HAV-IgM US Assay File
Abbott GmbH
08P281A
In Commercial Distribution

  • 00380740154448 ()
08P281A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740154431

Alinity i HAV-IgG US Assay File
Abbott GmbH
08P271A
In Commercial Distribution

  • 00380740154431 ()
08P271A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740154424

Alinity i HBsAgQu %N Assay File
Abbott GmbH
08P117A
In Commercial Distribution

  • 00380740154424 ()
08P117A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740153441

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

  • 00380740153441 ()
04P5721

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740153434

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
04P5518
Not in Commercial Distribution

  • 00380740153434 ()
04P5518

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740152147

ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740152130

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
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