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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 Type Device Class Implantable

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ARCHITECT - 00380740169046

ARCHITECT MULTIGENT e-ASSAY CD-ROM SI Units / Alternate Units
ABBOTT LABORATORIES
8K51-08
In Commercial Distribution

  • 00380740169046 ()
08K5108

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740169039

ARCHITECT MULTIGENT e-ASSAY CD-ROM Conventional Units / Alternate Units
ABBOTT LABORATORIES
8K50-08
In Commercial Distribution

  • 00380740169039 ()
08K5008

  • Laboratory instrument/analyser application software IVD

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 - 00380740162948

Alinity s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740162931

Alinity s HBsAg Confirmatory e-Assay File
Abbott GmbH
06P035A
In Commercial Distribution

  • 00380740162931 ()
06P035A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740162924

Alinity s HBsAg e-Assay File
Abbott GmbH
06P025A
In Commercial Distribution

  • 00380740162924 ()
06P025A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740162917

Alinity s Anti-HBc e-Assay File
Abbott GmbH
06P065A
In Commercial Distribution

  • 00380740162917 ()
06P065A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740162894

Alinity s Anti-HCV e-Assay File
Abbott GmbH
06P045A
In Commercial Distribution

  • 00380740162894 ()
06P045A

  • Laboratory instrument/analyser application software IVD
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