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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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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

Dade Hepzyme - 00630414640396

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873841
In Commercial Distribution

  • 00842768019487 ()
  • 00630414640396 ()
10873841

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00630414640389

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873840
In Commercial Distribution

  • 00630414640389 ()
10873840

  • Coagulation factor VIII IVD, kit, chromogenic

Dade Thrombin Reagent - 00630414640372

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873838
In Commercial Distribution

  • 00842768019500 ()
  • 00630414640372 ()
10873838

  • Fibrinogen assay (factor I) IVD, reagent

Dade Ci-Trol Heparin Control, High - 00630414640365

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873834
In Commercial Distribution

  • 00842768019531 ()
  • 00630414640365 ()
10873834

  • Multiple coagulation factor IVD, control

Dade Actin FSL Activated PTT Reagent - 00630414640358

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873832
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640358 ()
10873832

  • Activated partial thromboplastin time (APTT) IVD, reagent
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