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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 - 00380740132699

Alinity ci-series Calibrator/Control Replacement Caps
ABBOTT LABORATORIES
04R1001
In Commercial Distribution

  • 00380740132699 ()
  • 00380740163495 ()
04R1001

  • Multiple clinical chemistry analyser IVD, laboratory
  • Chemiluminescent immunoassay analyser IVD

Alinity - 00380740129675

Alinity ci-series Sample Cups
ABBOTT LABORATORIES
01R3801
In Commercial Distribution

  • 00380740129675 ()
  • 00380740163464 ()
01R3801

  • Chemiluminescent immunoassay analyser IVD
  • Multiple clinical chemistry analyser IVD, laboratory

Alinity - 00380740129026

Alinity Reaction Vessels
ABBOTT LABORATORIES
06P1401
In Commercial Distribution

  • 00380740129026 ()
  • 00380740163457 ()
06P1401

  • Chemiluminescent immunoassay analyser IVD
  • Multiple clinical chemistry analyser IVD, laboratory

ARCHITECT - 00380740012465

ABBOTT ARCHITECT Sample Cups
ABBOTT LABORATORIES
7C14-01
In Commercial Distribution

  • 00380740012465 ()
  • 00380740151096 ()
07C1401

  • Multiple clinical chemistry analyser IVD, laboratory
  • Chemiluminescent immunoassay analyser IVD

Ray 1 - 00627987231151

Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of fluorescence emitted from a wound when exposed to excitation light and ii) to capture and digitally record images through measuring surface temperature distribution.
Swift Medical Inc
SV403
In Commercial Distribution

  • 00627987231151 ()


  • Infrared thermography system
  • Fluorescence wound imaging unit

RX daytona plus - 05055273207781

The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4041
In Commercial Distribution

  • 05055273207781 ()
RX4041

  • Multiple clinical chemistry analyser IVD, laboratory

RX daytona plus - 05055273207774

The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4040
In Commercial Distribution

  • 05055273207774 ()
RX4040

  • Multiple clinical chemistry analyser IVD, laboratory

EQUIPOISE - 08908024776005

Device with hardware comprising a force plate and software for analysis of center of pressure during static and dynamic tests of stance.
EQUIDOR MEDTECH LLP
EQPOS
In Commercial Distribution

  • 08908024776005 ()


  • Posturography system

Procleix Xpress System - 00859882007948

The Procleix Xpress System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single Master Pool Tube (MPT), which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and MPT composition. The Procleix Xpress System is intended to create whole blood lysates and/or pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single MPT. The pooled or individual lysates may be used for further testing in Procleix systems. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 4.0
In Commercial Distribution

  • 00859882007948 ()
742248

  • Nucleic acid sample preparation instrument IVD

Procleix Xpress® System - 00859882007764

The Procleix Xpress System v2.1 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 2.1
In Commercial Distribution

  • 00859882007764 ()
741632

  • Pipetting system IVD
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