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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 - 00380740141585

Alinity c AST Assay File
Abbott GmbH
08P171A
In Commercial Distribution

  • 00380740141585 ()
08P171A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141578

Alinity c Total Prot Assay File
Abbott GmbH
07P521A
In Commercial Distribution

  • 00380740141578 ()
07P521A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740139537

ARCHITECT i1000SR System e-Assay CDROM
ABBOTT LABORATORIES
4P57-19
Not in Commercial Distribution

  • 00380740139537 ()
04P5719

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740139520

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-16
Not in Commercial Distribution

  • 00380740139520 ()
04P5516

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740138899

Alinity i TSH Assay File
Abbott GmbH
07P481A
In Commercial Distribution

  • 00380740138899 ()
07P481A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740138615

ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-18
Not in Commercial Distribution

  • 00380740138615 ()
04P5718

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740138608

ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-15
Not in Commercial Distribution

  • 00380740138608 ()
04P5515

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740007584

ARCHITECT cSystems Assay Disk SI Units version 22.0
ABBOTT LABORATORIES
04J6225
In Commercial Distribution

  • 00380740007584 ()
04J6225

  • Laboratory instrument/analyser application software IVD

WaveLight - 00380659984372

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

AlinIQ - 00380740216658

AlinIQ AMS
ABBOTT SRL
03R8967
In Commercial Distribution

  • 00380740216658 ()
03R8967

  • Laboratory instrument/analyser application software IVD
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