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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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Alinity s Anti-HCV II Assay File
Abbott GmbH
04W565A
In Commercial Distribution

  • 00380740198930 ()
04W565A

  • Laboratory instrument/analyser application software IVD
Alinity i HAVAb IgG II Assay File
Abbott GmbH
06S931A
In Commercial Distribution

  • 00380740197544 ()
06S931A

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R8959
In Commercial Distribution

  • 00380740196875 ()
03R8959

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk SI Units version 18.0
ABBOTT LABORATORIES
04J6221
In Commercial Distribution

  • 00380740195502 ()
04J6221

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk Conventional Units version 18.0
ABBOTT LABORATORIES
08G9821
In Commercial Distribution

  • 00380740195496 ()
08G9821

  • Laboratory instrument/analyser application software IVD
Alinity i Free T4 Assay File
Abbott GmbH
07P701C
In Commercial Distribution

  • 00380740195458 ()
07P701C

  • Laboratory instrument/analyser application software IVD
Alinity c A-ALT Assay File
Abbott GmbH
08P181B
In Commercial Distribution

  • 00380740195380 ()
08P181B

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HBs
Abbott GmbH
07P885A
In Commercial Distribution

  • 00380740195205 ()
07P885A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM-US Version 4.0
ABBOTT LABORATORIES
06R8904
In Commercial Distribution

  • 00380740194826 ()
06R8904

  • Laboratory instrument/analyser application software IVD
Alinity i HSV-1 IgG Assay File
Abbott GmbH
04W201A
In Commercial Distribution

  • 00380740194758 ()
04W201A

  • Laboratory instrument/analyser application software IVD
Alinity c BenzSQ Assay File
Abbott GmbH
09P523B
In Commercial Distribution

  • 00380740194208 ()
09P523B

  • Laboratory instrument/analyser application software IVD
Alinity c BenzQ Assay File
Abbott GmbH
09P521B
In Commercial Distribution

  • 00380740194192 ()
09P521B

  • Laboratory instrument/analyser application software IVD
Alinity i COV 2IgGII Assay File
Abbott GmbH
06S611A
In Commercial Distribution

  • 00380740194093 ()
06S611A

  • Laboratory instrument/analyser application software IVD
Alinity i STAT High Sensitivity Tropopnin-I
Abbott GmbH
04Z211A
In Commercial Distribution

  • 00380740193638 ()
04Z211A

  • Laboratory instrument/analyser application software IVD
Alinity i Free T4 Assay File
Abbott GmbH
07P701B
In Commercial Distribution

  • 00380740193577 ()
07P701B

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM-US Version 3.0
ABBOTT LABORATORIES
06R8903
In Commercial Distribution

  • 00380740192846 ()
06R8903

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 25.0
ABBOTT LABORATORIES
04P5725
In Commercial Distribution

  • 00380740192761 ()
04P5725

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 23.0
ABBOTT LABORATORIES
04P5523
In Commercial Distribution

  • 00380740192754 ()
04P5523

  • Laboratory instrument/analyser application software IVD
Alinity c Uric2-U Assay File
Abbott GmbH
04U093A
In Commercial Distribution

  • 00380740192723 ()
04U093A

  • Laboratory instrument/analyser application software IVD
Alinity i COV-2 IgM Assay File
Abbott GmbH
06R911A
In Commercial Distribution

  • 00380740192464 ()
06R911A

  • Laboratory instrument/analyser application software IVD
Alinity i COV-2 IgG Assay File
Abbott GmbH
06R901A
In Commercial Distribution

  • 00380740192457 ()
06R901A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM - US Version 2.0
ABBOTT LABORATORIES
06R8902
Not in Commercial Distribution

  • 00380740192426 ()
06R8902

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM - US
ABBOTT LABORATORIES
04P5522
In Commercial Distribution

  • 00380740192372 ()
04P5522

  • Laboratory instrument/analyser application software IVD
ARCHITECT Uric2 SI Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04T133A
In Commercial Distribution

  • 00380740191382 ()
04T133A

  • Laboratory instrument/analyser application software IVD
ARCHITECT Uric2 Conventional Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04T131A
In Commercial Distribution

  • 00380740191375 ()
04T131A

  • Laboratory instrument/analyser application software IVD
ARCHITECT Iron2 SI Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04T023A
In Commercial Distribution

  • 00380740191245 ()
04T023A

  • Laboratory instrument/analyser application software IVD
ARCHITECT Iron2 Conventional Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04T021A
In Commercial Distribution

  • 00380740191238 ()
04T021A

  • Laboratory instrument/analyser application software IVD
ARCHITECT GGT2 SI Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04T003A
In Commercial Distribution

  • 00380740191207 ()
04T003A

  • Laboratory instrument/analyser application software IVD
ARCHITECT GGT2 Conventional Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04T001A
In Commercial Distribution

  • 00380740191191 ()
04T001A

  • Laboratory instrument/analyser application software IVD
ARCHITECT AST2 SI Units e-Assay CD-ROM version 1.0
ABBOTT LABORATORIES
04S903A
In Commercial Distribution

  • 00380740191085 ()
04S903A

  • Laboratory instrument/analyser application software IVD
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