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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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BCS® XP System - 00630414945514

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

Coagulation Factor VII Deficient Plasma - 00630414640792

For the determination of the activity of coagulation factor VII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873879
In Commercial Distribution

  • 00842768018848 ()
  • 00630414640792 ()
10873879

  • Coagulation factor VII IVD, reagent

Coagulation Factor VIII Deficient Plasma - 00630414640761

For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873880
In Commercial Distribution

  • 00842768018831 ()
  • 00630414640761 ()
10873880

  • Coagulation factor VIII IVD, reagent

Coagulation Factor V Deficient Plasma - 00630414640754

For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873876
In Commercial Distribution

  • 00842768018886 ()
  • 00630414640754 ()
10873876

  • Coagulation factor V IVD, reagent

Control Plasma N - 00630414640747

Assayed control used to monitor the performance of coagulation assays in the normal range
Siemens Healthcare Diagnostics Products GmbH
10873874
In Commercial Distribution

  • 00842768018909 ()
  • 00630414640747 ()
10873874

  • Multiple coagulation factor IVD, control

Pathromtin SL - 00630414640716

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873863
In Commercial Distribution

  • 00842768019074 ()
  • 00630414640716 ()
10873863

  • Activated partial thromboplastin time (APTT) IVD, reagent

Pathromtin SL - 00630414640709

Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873862
In Commercial Distribution

  • 00842768019074 ()
  • 00630414640709 ()
10873862

  • Activated partial thromboplastin time (APTT) IVD, reagent

Coagulation Factor II Deficient Plasma - 00630414640686

For the determination of the activity of coagulation factor II (prothrombin) in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873878
In Commercial Distribution

  • 00842768018855 ()
  • 00630414640686 ()
10873878

  • Coagulation factor II (prothrombin) IVD, reagent

Coagulation Factor XII Deficient Plasma - 00630414640679

For the determination of the activity of coagulation factor XII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873877
In Commercial Distribution

  • 00842768018862 ()
  • 00630414640679 ()
10873877

  • Coagulation factor XII IVD, reagent

Protein C Reagent - 00630414640655

Coagulation test for the quantitative determination of protein C activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873871
In Commercial Distribution

  • 00630414640655 ()
10873871

  • Protein C IVD, kit, clotting

Fibrinogen Calibrator Kit - 00630414640631

Calibrators for the assay of fibrinogen by the method of Clauss using Multifibren U
Siemens Healthcare Diagnostics Products GmbH
10873868
In Commercial Distribution

  • 00630414640631 ()
10873868

  • Fibrinogen assay (factor I) IVD, calibrator

ProC Control Plasma - 00630414640624

Assayed control to monitor the performance of Factor V Leiden assay in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10873865
In Commercial Distribution

  • 00842768019005 ()
  • 00630414640624 ()
10873865

  • Protein C IVD, control

Coagulation Factor IX Deficient Plasma - 00630414640587

For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873881
In Commercial Distribution

  • 00842768018824 ()
  • 00630414640587 ()
10873881

  • Coagulation factor IX IVD, reagent

Calcium Chloride Solution - 00630414640563

Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10873872
In Commercial Distribution

  • 00842768018916 ()
  • 00630414640563 ()
10873872

  • Calcium chloride coagulation reagent IVD

Kaolin Suspension - 00630414640532

Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10873859
In Commercial Distribution

  • 00630414640532 ()
10873859

  • Fibrinogen assay (factor I) IVD, reagent

INNOVANCE D-Dimer - 00630414640501

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10873853
In Commercial Distribution

  • 00630414640501 ()
10873853

  • D-dimer IVD, kit, agglutination

INNOVANCE D-Dimer - 00630414640488

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10873852
In Commercial Distribution

  • 00630414640488 ()
10873852

  • D-dimer IVD, kit, agglutination

Protein S Ac - 00630414640457

Determination of the functional activity of protein S in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873846
In Commercial Distribution

  • 00630414640457 ()
10873846

  • Protein S IVD, kit, clotting

vWF Ag - 00630414640433

For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873845
In Commercial Distribution

  • 00630414640433 ()
10873845

  • Coagulation factor VIII-associated antigen IVD, kit, nephelometry/turbidimetry

Dade Ci-Trol Coagulation Control Level 3 - 00630414640426

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873844
In Commercial Distribution

  • 00842768019456 ()
  • 00630414640426 ()
10873844

  • Multiple coagulation factor IVD, control
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