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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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Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye.
Alcon Laboratories, Inc.
1023
In Commercial Distribution

  • 00380659984372 ()
8065998437

  • Eye anterior segment analyser
BD FACSuite™ Clinical BD Leucocount™ Assay Module
Becton, Dickinson And Company
665732
In Commercial Distribution

  • 00382906657329 ()
665732

  • Laboratory instrument/analyser application software IVD
BD FACSDiva™ v9.0.1
Becton, Dickinson And Company
664345
In Commercial Distribution

  • 00382906643452 ()
664345

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical, BD Multitest™ 6-Color Assays
Becton, Dickinson And Company
664237
In Commercial Distribution

  • 00382906642370 ()
664237

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical, BD Multitest™ 4-Color Assays
Becton, Dickinson And Company
664236
In Commercial Distribution

  • 00382906642363 ()
664236

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical Application
Becton, Dickinson And Company
664235
In Commercial Distribution

  • 00382906642356 ()
664235

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical BD Multitest™ 6-Color Assays v1.0
Becton, Dickinson And Company
663007
In Commercial Distribution

  • 00382906630070 ()
663007

  • Laboratory instrument/analyser application software IVD
BD FACSuite™ Clinical BD Multitest™ 4-Color Assays v1.0
Becton, Dickinson And Company
663005
In Commercial Distribution

  • 00382906630056 ()
663005

  • Laboratory instrument/analyser application software IVD
BD® HLA-B27 Application Module v2.0
BECTON, DICKINSON AND COMPANY
657987
Not in Commercial Distribution

  • 00382906579874 ()
657987

  • Laboratory instrument/analyser application software IVD
FACSDiva 8.0 Upgrade Version No Dongle
BECTON, DICKINSON AND COMPANY
657925
Not in Commercial Distribution

  • 00382906579256 ()
657925

  • Laboratory instrument/analyser application software IVD
FACSCanto II 3.0 SW without dongle
BECTON, DICKINSON AND COMPANY
657880
Not in Commercial Distribution

  • 00382906578808 ()
657880

  • Laboratory instrument/analyser application software IVD
FACSCanto II 3.0 SW with dongle
BECTON, DICKINSON AND COMPANY
657769
Not in Commercial Distribution

  • 00382906577696 ()
657769

  • Laboratory instrument/analyser application software IVD
BD FACSCANTO System SW V3.0 W/Dongle
BECTON, DICKINSON AND COMPANY
657766
Not in Commercial Distribution

  • 00382906577665 ()
657766

  • Laboratory instrument/analyser application software IVD
FACSCanto V2.4 SW With Dongle
BECTON, DICKINSON AND COMPANY
657081
Not in Commercial Distribution

  • 00382906570819 ()
657081

  • Laboratory instrument/analyser application software IVD
Multiset SW V3.0.2/User Guide Bundle
Becton, Dickinson And Company
643437
In Commercial Distribution

  • 00382906434371 ()
643437

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R8967
In Commercial Distribution

  • 00380740216658 ()
03R8967

  • Laboratory instrument/analyser application software IVD
Alere NT-proBNP for Alinity I Assay File
Abbott GmbH
04S793A
In Commercial Distribution

  • 00380740216085 ()
04S793A

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk Conventional Units version 22.0
ABBOTT LABORATORIES
08G9825
In Commercial Distribution

  • 00380740215033 ()
08G9825

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 30.0
ABBOTT LABORATORIES
04P5730
In Commercial Distribution

  • 00380740214487 ()
04P5730

  • Laboratory instrument/analyser application software IVD
Alinity c TCAQ1 Assay File
Abbott GmbH
09P917A
In Commercial Distribution

  • 00380740214388 ()
09P917A

  • Laboratory instrument/analyser application software IVD
Alinity c TCASQ1 Assay File
Abbott GmbH
09P915A
In Commercial Distribution

  • 00380740214371 ()
09P915A

  • Laboratory instrument/analyser application software IVD
Alinity c TBili2 Assay File
Abbott GmbH
04U051B
In Commercial Distribution

  • 00380740213978 ()
04U051B

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 29.0
ABBOTT LABORATORIES
04P5729
In Commercial Distribution

  • 00380740213862 ()
04P5729

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM-US Version 28.0
ABBOTT LABORATORIES
04P5728
In Commercial Distribution

  • 00380740213855 ()
04P5728

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk SI Units version 21.0
ABBOTT LABORATORIES
04J6224
In Commercial Distribution

  • 00380740213848 ()
04J6224

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk Conventional Units version 21.0
ABBOTT LABORATORIES
08G9824
In Commercial Distribution

  • 00380740213831 ()
08G9824

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System SARS-COV-2 IgG/IgM e-Assay CD-ROM – US Version 5.0
ABBOTT LABORATORIES
06R8905
In Commercial Distribution

  • 00380740213503 ()
06R8905

  • Laboratory instrument/analyser application software IVD
Alinity c ALT2F Assay File
Abbott GmbH
04T843B
In Commercial Distribution

  • 00380740213084 ()
04T843B

  • Laboratory instrument/analyser application software IVD
Alinity c ALT2 Assay File
Abbott GmbH
04T841B
In Commercial Distribution

  • 00380740213077 ()
04T841B

  • Laboratory instrument/analyser application software IVD
Alinity c Crea2 Urine Assay File
Abbott GmbH
04T913B
In Commercial Distribution

  • 00380740212827 ()
04T913B

  • Laboratory instrument/analyser application software IVD
Alinity c Crea2 Assay File
Abbott GmbH
04T911B
In Commercial Distribution

  • 00380740212810 ()
04T911B

  • Laboratory instrument/analyser application software IVD
Alinity c AlbBCP2 Assay File
Abbott GmbH
04T821B
In Commercial Distribution

  • 00380740212803 ()
04T821B

  • Laboratory instrument/analyser application software IVD
Alinity c AlbBCG2 Assay File
Abbott GmbH
04U301B
In Commercial Distribution

  • 00380740212797 ()
04U301B

  • Laboratory instrument/analyser application software IVD
AlinIQ AMS
ABBOTT SRL
03R8965
In Commercial Distribution

  • 00380740212575 ()
03R8965

  • Laboratory instrument/analyser application software IVD
ARCHITECT i100SR System e-Assay CD-ROM-US Version 27.0
ABBOTT LABORATORIES
04P5727
In Commercial Distribution

  • 00380740211431 ()
04P5727

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM-US Version 26.0
ABBOTT LABORATORIES
04P5526
In Commercial Distribution

  • 00380740211424 ()
04P5526

  • Laboratory instrument/analyser application software IVD
Alinity c IgE-US Assay File
Abbott GmbH
01R133A
In Commercial Distribution

  • 00380740209544 ()
01R133A

  • Laboratory instrument/analyser application software IVD
Alinity i STAT High Sensitivity Troponin-I
Abbott GmbH
04Z211B
In Commercial Distribution

  • 00380740209438 ()
04Z211B

  • Laboratory instrument/analyser application software IVD
Alinity i UCH-L1 Assay File
Abbott GmbH
04W191B
In Commercial Distribution

  • 00380740208936 ()
04W191B

  • Laboratory instrument/analyser application software IVD
Alinity i GFAP Assay File
Abbott GmbH
04W171B
In Commercial Distribution

  • 00380740208929 ()
04W171B

  • Laboratory instrument/analyser application software IVD
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