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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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Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.
IMMUCOR, INC.
0007865
In Commercial Distribution

  • 10888234000877 ()
0007865

  • Red cell antibody eluting IVD, kit
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 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 ROTROL P
In Commercial Distribution

  • 04260160470624 ()
  • 04260160470358 ()
555202

  • Multiple coagulation factor IVD, control
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 ROTROL N
In Commercial Distribution

  • 04260160470617 ()
  • 04260160470341 ()
555201

  • Multiple coagulation factor IVD, control
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 complete + hep
In Commercial Distribution

  • 04260160470600 ()
  • 04260160470327 ()
555502

  • Multiple coagulation factor IVD, kit, clotting
The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
Tem Innovations GmbH
ex-tem®
In Commercial Distribution

  • 04260160470242 ()
  • 04260160470471 ()
503-05-US

  • Multiple coagulation factor IVD, reagent
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF).
Tem Innovations GmbH
fib-tem®
In Commercial Distribution

  • 04260160470075 ()
  • 04260160470495 ()
503-06-US

  • Multiple coagulation factor IVD, reagent
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
Tem Innovations GmbH
ap-tem®
In Commercial Distribution

  • 04260160470068 ()
  • 04260160470488 ()
503-04-US

  • Multiple coagulation factor IVD, reagent
CITRATED: K, KH, RTH, FFH
HAEMONETICS CORPORATION
07-604-US
In Commercial Distribution

  • 20812747018538 ()
  • 10812747018531 ()


  • Multiple coagulation factor IVD, reagent
Citrated: K, RT, FF
HAEMONETICS CORPORATION
07-605-US
In Commercial Distribution

  • 20812747018460 ()
  • 10812747018463 ()


  • Multiple coagulation factor IVD, reagent
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