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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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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

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 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

Dade Actin FS Activated PTT Reagent - 00630414640341

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873830
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640341 ()
10873830

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin Activated Cephaloplastin Reagent - 00630414640334

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873829
In Commercial Distribution

  • 00842768019579 ()
  • 00630414640334 ()
10873829

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin FS Activated PTT Reagent - 00630414640327

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873828
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640327 ()
10873828

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin Activated Cephaloplastin Reagent - 00630414640310

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873827
In Commercial Distribution

  • 00842768019579 ()
  • 00630414640310 ()
10873827

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Ci-Trol Coagulation Control Level 2 - 00630414640280

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873843
In Commercial Distribution

  • 00842768019463 ()
  • 00630414640280 ()
10873843

  • Multiple coagulation factor IVD, control

Dade Thrombin Reagent - 00630414640266

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873837
In Commercial Distribution

  • 00842768019517 ()
  • 00630414640266 ()
10873837

  • Fibrinogen assay (factor I) IVD, reagent

Dade Actin FSL Activated PTT Reagent - 00630414640242

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
10873831
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640242 ()
10873831

  • Activated partial thromboplastin time (APTT) IVD, reagent

LA Control Low - 00630414640013

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873935
In Commercial Distribution

  • 00842768019678 ()
  • 00630414640013 ()
10873935

  • Lupus anticoagulant marker IVD, control

Dade Innovin - 00630414640006

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873933
In Commercial Distribution

  • 00842768019586 ()
  • 00630414640006 ()
10873933

  • Prothrombin time (PT) IVD, reagent

Thromborel S - 00630414639963

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873931
In Commercial Distribution

  • 00842768018749 ()
  • 00630414639963 ()
10873931

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin LMW Control 1 - 00630414639956

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873929
In Commercial Distribution

  • 00630414229539 ()
  • 00630414639956 ()
10873929

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00630414639949

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873926
In Commercial Distribution

  • 00630414229515 ()
  • 00630414639949 ()
10873926

  • Heparin anti-Xa IVD, control

Dade CA System Buffer - 00630414639901

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873915
In Commercial Distribution

  • 00842768019845 ()
  • 00630414639901 ()
10873915

  • Buffered sample diluent IVD

Dade Innovin - 00630414639888

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873934
In Commercial Distribution

  • 00842768019609 ()
  • 00630414639888 ()
10873934

  • Prothrombin time (PT) IVD, reagent

Dade Innovin - 00630414639871

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873932
In Commercial Distribution

  • 00842768019593 ()
  • 00630414639871 ()
10873932

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin - 00630414639864

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873930
In Commercial Distribution

  • 00630414639864 ()
10873930

  • Heparin anti-Xa IVD, kit, chromogenic
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