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

  • 00380740166465 ()
04P5724

  • Laboratory instrument/analyser application software IVD
ARCHITECT iSystem e-Assay CD-ROM
ABBOTT LABORATORIES
04P5521
Not in Commercial Distribution

  • 00380740166458 ()
04P5521

  • Laboratory instrument/analyser application software IVD
Alinity c Lithium Assay File
Abbott GmbH
08P531B
In Commercial Distribution

  • 00380740166441 ()
08P531B

  • Laboratory instrument/analyser application software IVD
Alinity s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg Confirmatory e-Assay File
Abbott GmbH
06P035A
In Commercial Distribution

  • 00380740162931 ()
06P035A

  • Laboratory instrument/analyser application software IVD
Alinity s HBsAg e-Assay File
Abbott GmbH
06P025A
In Commercial Distribution

  • 00380740162924 ()
06P025A

  • Laboratory instrument/analyser application software IVD
Alinity s Anti-HBc e-Assay File
Abbott GmbH
06P065A
In Commercial Distribution

  • 00380740162917 ()
06P065A

  • Laboratory instrument/analyser application software IVD
Alinity s Anti-HCV e-Assay File
Abbott GmbH
06P045A
In Commercial Distribution

  • 00380740162894 ()
06P045A

  • Laboratory instrument/analyser application software IVD
Alinity s HIV Ag/Ab Combo e-Assay File
Abbott GmbH
06P015A
In Commercial Distribution

  • 00380740162887 ()
06P015A

  • Laboratory instrument/analyser application software IVD
Alinity s Chagas e-Assay File
Abbott GmbH
06P085A
In Commercial Distribution

  • 00380740162863 ()
06P085A

  • Laboratory instrument/analyser application software IVD
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