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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 - 00380740166465

ARCHITECT i1000SR System e-Assay CD-ROM - US
ABBOTT LABORATORIES
04P5724
In Commercial Distribution

  • 00380740166465 ()
04P5724

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740166458

ARCHITECT iSystem e-Assay CD-ROM
ABBOTT LABORATORIES
04P5521
Not in Commercial Distribution

  • 00380740166458 ()
04P5521

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740166441

Alinity c Lithium Assay File
Abbott GmbH
08P531B
In Commercial Distribution

  • 00380740166441 ()
08P531B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740162849

Alinity i CK-MB STAT Assay File
Abbott GmbH
04V381A
In Commercial Distribution

  • 00380740162849 ()
04V381A

  • 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

ARCHITECT - 00380740161316

ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00
ABBOTT LABORATORIES
8K50-07
In Commercial Distribution

  • 00380740161316 ()
08K5007

  • 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

Alinity - 00380740160791

Alinity c Iron Assay File
Abbott GmbH
08P391B
In Commercial Distribution

  • 00380740160791 ()
08P391B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740160784

Alinity c MagnesiumU Assay File
Abbott GmbH
08P193B
In Commercial Distribution

  • 00380740160784 ()
08P193B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740160777

Alinity c Magnesium Assay File
Abbott GmbH
08P191B
In Commercial Distribution

  • 00380740160777 ()
08P191B

  • Laboratory instrument/analyser application software IVD
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