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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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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

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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