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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 - 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

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 - 00380740155865

Alinity c SerBENZSQ Assay File
Abbott GmbH
09P531A
In Commercial Distribution

  • 00380740155865 ()
09P531A

  • 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
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