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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 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

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
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