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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 Type Device Class Implantable

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ORTHO - 10758750005499

OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD

STA Coag Expert® - 03607450871111

No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450871111 ()
87111

  • Laboratory instrument/analyser application software IVD

Coag.One server license - 03607450867657

No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450867657 ()
86765

  • Laboratory instrument/analyser application software IVD

Coag.One server license - 03607450000047

No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000047 ()
86765

  • Laboratory instrument/analyser application software IVD

STA Coag Expert® - 03607450000030

No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000030 ()
87111

  • Laboratory instrument/analyser application software IVD

Acuitas - 01812125010081

Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution

  • 01812125010081 ()
CP3511

  • Laboratory instrument/analyser application software IVD

dIFine ANCA Classifier - 08059304340239

No Description
VISIA LAB SRL
dIFine ANCA Classifier
In Commercial Distribution

  • 08059304340239 ()


  • Laboratory instrument/analyser application software IVD

dIFine DNA Classifier - 08059304340222

No Description
VISIA LAB SRL
dIFine DNA Classifier
In Commercial Distribution

  • 08059304340222 ()


  • Laboratory instrument/analyser application software IVD

dIFine ANA HEp-2 Classifier - 08059304340215

No Description
VISIA LAB SRL
dIFine ANA HEp-2 Classifier
In Commercial Distribution

  • 08059304340215 ()


  • Laboratory instrument/analyser application software IVD

cobas Liat Influenza AB Script Version 1.33 - 07613336156551

No Description
Roche Molecular Systems, Inc.
08403864001
Not in Commercial Distribution

  • 07613336156551 ()
08403864001

  • Laboratory instrument/analyser application software IVD
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