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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 - 00380740141851

Alinity c CreaU Assay File
Abbott GmbH
07P993A
In Commercial Distribution

  • 00380740141851 ()
07P993A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141844

Alinity c Creatinine Assay File
Abbott GmbH
07P991A
In Commercial Distribution

  • 00380740141844 ()
07P991A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141837

Alinity c Calcium U Assay File
Abbott GmbH
07P573A
In Commercial Distribution

  • 00380740141837 ()
07P573A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141820

Alinity c Calcium Assay File
Abbott GmbH
07P571A
In Commercial Distribution

  • 00380740141820 ()
07P571A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141813

Alinity c UreaU Assay File
Abbott GmbH
08P163A
In Commercial Distribution

  • 00380740141813 ()
08P163A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141806

Alinity c Urea Assay File
Abbott GmbH
08P161A
In Commercial Distribution

  • 00380740141806 ()
08P161A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141790

Alinity c ALT Assay File
Abbott GmbH
07P981A
In Commercial Distribution

  • 00380740141790 ()
07P981A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141783

Alinity c CO2 Assay File
Abbott GmbH
07P721A
In Commercial Distribution

  • 00380740141783 ()
07P721A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141776

Alinity c GGT-Conv Assay File
Abbott GmbH
07P733A
In Commercial Distribution

  • 00380740141776 ()
07P733A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141769

Alinity c GGT Assay File
Abbott GmbH
07P731A
In Commercial Distribution

  • 00380740141769 ()
07P731A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141752

Alinity c PhosU Assay File
Abbott GmbH
08P403A
In Commercial Distribution

  • 00380740141752 ()
08P403A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141745

Alinity c Phosphorus Assay File
Abbott GmbH
08P401A
In Commercial Distribution

  • 00380740141745 ()
08P401A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141738

Alinity c Trig Assay File
Abbott GmbH
07P771A
In Commercial Distribution

  • 00380740141738 ()
07P771A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141721

Alinity c Ultra HDL Assay File
Abbott GmbH
07P751A
In Commercial Distribution

  • 00380740141721 ()
07P751A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141714

Alinity c UricU Assay File
Abbott GmbH
08P563A
In Commercial Distribution

  • 00380740141714 ()
08P563A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141707

Alinity c Uric Acid Assay File
Abbott GmbH
08P561A
In Commercial Distribution

  • 00380740141707 ()
08P561A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141684

Alinity c CK Assay File
Abbott GmbH
08P421A
In Commercial Distribution

  • 00380740141684 ()
08P421A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141677

Alinity c LDH Assay File
Abbott GmbH
07P741A
In Commercial Distribution

  • 00380740141677 ()
07P741A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141660

Alinity c Chol Assay File
Abbott GmbH
07P761A
In Commercial Distribution

  • 00380740141660 ()
07P761A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141653

Alinity c AlkP Assay File
Abbott GmbH
08P201A
In Commercial Distribution

  • 00380740141653 ()
08P201A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141646

Alinity c Cl-CU Assay File
Abbott GmbH
07P536A
In Commercial Distribution

  • 00380740141646 ()
07P536A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141639

Alinity c Cl-C Assay File
Abbott GmbH
07P535A
In Commercial Distribution

  • 00380740141639 ()
07P535A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141622

Alinity c K-CU Assay File
Abbott GmbH
07P534A
In Commercial Distribution

  • 00380740141622 ()
07P534A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141615

Alinity c K-C Assay File
Abbott GmbH
07P533A
In Commercial Distribution

  • 00380740141615 ()
07P533A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141608

Alinity c Na-CU Assay File
Abbott GmbH
07P532A
In Commercial Distribution

  • 00380740141608 ()
07P532A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740141592

Alinity c Na-C Assay File
Abbott GmbH
07P531A
In Commercial Distribution

  • 00380740141592 ()
07P531A

  • Laboratory instrument/analyser application software IVD

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

Alinity - 00380740216085

Alere NT-proBNP for Alinity I Assay File
Abbott GmbH
04S793A
In Commercial Distribution

  • 00380740216085 ()
04S793A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740215033

ARCHITECT cSystems Assay Disk Conventional Units version 22.0
ABBOTT LABORATORIES
08G9825
In Commercial Distribution

  • 00380740215033 ()
08G9825

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740214487

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 - 00380740214388

Alinity c TCAQ1 Assay File
Abbott GmbH
09P917A
In Commercial Distribution

  • 00380740214388 ()
09P917A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740214371

Alinity c TCASQ1 Assay File
Abbott GmbH
09P915A
In Commercial Distribution

  • 00380740214371 ()
09P915A

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740213978

Alinity c TBili2 Assay File
Abbott GmbH
04U051B
In Commercial Distribution

  • 00380740213978 ()
04U051B

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213862

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 - 00380740213855

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 - 00380740213848

ARCHITECT cSystems Assay Disk SI Units version 21.0
ABBOTT LABORATORIES
04J6224
In Commercial Distribution

  • 00380740213848 ()
04J6224

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213831

ARCHITECT cSystems Assay Disk Conventional Units version 21.0
ABBOTT LABORATORIES
08G9824
In Commercial Distribution

  • 00380740213831 ()
08G9824

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740213503

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 - 00380740213084

Alinity c ALT2F Assay File
Abbott GmbH
04T843B
In Commercial Distribution

  • 00380740213084 ()
04T843B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740213077

Alinity c ALT2 Assay File
Abbott GmbH
04T841B
In Commercial Distribution

  • 00380740213077 ()
04T841B

  • Laboratory instrument/analyser application software IVD

Alinity - 00380740212827

Alinity c Crea2 Urine Assay File
Abbott GmbH
04T913B
In Commercial Distribution

  • 00380740212827 ()
04T913B

  • Laboratory instrument/analyser application software IVD
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