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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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Automated Microscope
AGILENT TECHNOLOGIES, INC.
LLX-SI
In Commercial Distribution

  • 05700574035105 ()

  • No Device Sizes


  • Cell morphology analyser IVD, automated/semi-automated
Bolt EIA-CLIA (refurbished)
Gold Standard Diagnostics Corporation
00500-CLR
In Commercial Distribution

  • B35000500CLR0 ()
00500-CLR

  • Chemiluminescent immunoassay analyser IVD
  • Enzyme immunoassay (EIA) analyser IVD
Bolt EIA-CLIA
Gold Standard Diagnostics Corporation
00500-CL
In Commercial Distribution

  • B35000500CL0 ()
00500CL

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD
ThunderBolt EIA-CLIA (refurbished)
Gold Standard Diagnostics Corporation
00300-CLR
In Commercial Distribution

  • B35000300CLR0 ()
00300-CLR

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD
ThunderBolt EIA-CLIA
Gold Standard Diagnostics Corporation
00300-CL
In Commercial Distribution

  • B35000300CL0 ()
00300CL

  • Enzyme immunoassay (EIA) analyser IVD
  • Chemiluminescent immunoassay analyser IVD
No Description
Zimmer Us, Inc.
MMAND001
In Commercial Distribution

  • 00887868517747 ()
MMAND001

  • Biomechanical function analysis/rehabilitation software
No Description
Zimmer Us, Inc.
MMIOS001
In Commercial Distribution

  • 00887868517730 ()
MMIOS001

  • Biomechanical function analysis/rehabilitation software
No Description
Zimmer Us, Inc.
MMCWE001
In Commercial Distribution

  • 00887868517723 ()
MMCWE001

  • Biomechanical function analysis/rehabilitation software
MR3 - myoVIDEO
Noraxon U.S.A., Inc.
403
In Commercial Distribution

  • 00816271020780 ()
403

  • Biomechanical function analysis/rehabilitation software
MR3 - myoMOTION
Noraxon U.S.A., Inc.
405
In Commercial Distribution

  • 00816271020742 ()
405

  • Biomechanical function analysis/rehabilitation software
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