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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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Acuitas - 20812125010086

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

  • 20812125010086 ()
CP3511

  • Laboratory instrument/analyser application software IVD

HemoCue® 801 Connect - 07311091391681

HemoCue® 801 Connect
Hemocue AB
139168
Not in Commercial Distribution

  • 07311091391681 ()
139168

  • Laboratory instrument/analyser application software IVD

Phadia Prime - 07333066015101

Phadia Prime
Phadia AB
12-4101-00
In Commercial Distribution

  • 07333066015101 ()
12-4101-00

  • Laboratory instrument/analyser application software IVD

Phadia Information Data Manager Software Package - 07333066001012

Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution

  • 07333066001012 ()
12-3801-11

  • Laboratory instrument/analyser application software IVD

DI Remote Review Software version 6.x.x - 07350040975930

The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
AG516335
In Commercial Distribution

  • 07350040975930 ()
AG516335

  • Laboratory instrument/analyser application software IVD

CellaVision® Remote Review Software, Enterprise Edition, version independent - 07350040975923

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-EN0099
In Commercial Distribution

  • 07350040975923 ()
CRRS-GR0099

  • Laboratory instrument/analyser application software IVD

CellaVision® Remote Review Software, Group Edition, version independent - 07350040975916

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-GR0099
In Commercial Distribution

  • 07350040975916 ()
CRRS-GR0099

  • Laboratory instrument/analyser application software IVD

CellaVision® Remote Review Software, Team Edition, version independent - 07350040975909

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-TE0099
In Commercial Distribution

  • 07350040975909 ()
CRRS-TE0099

  • Laboratory instrument/analyser application software IVD

CellaVision® Remote Review Software, Professional Edition, version independent - 07350040975893

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-PR0099
In Commercial Distribution

  • 07350040975893 ()
CRRS-PR0099

  • Laboratory instrument/analyser application software IVD

For DI Advanced RBC Application - 07350040974759

When implemented together with DI-60 and software, the Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics
Cellavision AB
AB859211
In Commercial Distribution

  • 07350040974759 ()
AB859211

  • Laboratory instrument/analyser application software IVD
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