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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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For Use with the QUANTRA® Hemostasis Analyzer
HEMOSONICS, LLC
QStat Control Level 1 Kit (Box of 4)
In Commercial Distribution

  • 00850003761336 ()


  • Coagulation analyser IVD, laboratory
The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.
Tem Innovations GmbH
sigma
In Commercial Distribution

  • 04260160470372 ()
211000

  • Coagulation analyser IVD, laboratory
The BCS Cuvette Rotor is part of the BCS-XP system.
Siemens Healthcare Diagnostics Products GmbH
10446524
In Commercial Distribution

  • 00842768014444 ()
  • 00842768024603 ()
OVIP15

  • Coagulation analyser IVD, laboratory
Behring Coagulation Cup serves as vessel for samples, human plasma and buffer solutions.
Siemens Healthcare Diagnostics Products GmbH
10446526
In Commercial Distribution

  • 00842768012198 ()
  • 00842768024757 ()
OVIS31

  • Coagulation analyser IVD, laboratory
The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10459330
In Commercial Distribution

  • 00630414945514 ()
OVOB03

  • Coagulation analyser IVD, laboratory
a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.
SYSMEX CORPORATION
CK978289
In Commercial Distribution

  • 04987562518685 ()


  • Coagulation analyser IVD, laboratory
A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use
SYSMEX CORPORATION
BR142626
In Commercial Distribution

  • 04987562518678 ()


  • Coagulation analyser IVD, laboratory
A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562518661 ()


  • Coagulation analyser IVD, laboratory
A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
SYSMEX CORPORATION
BY990757
In Commercial Distribution

  • 04987562518654 ()


  • Coagulation analyser IVD, laboratory
CS-2500 COMPLETE
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562433735 ()


  • Coagulation analyser IVD, laboratory
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