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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

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

Dade Owren's Veronal Buffer - 00630414640273

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873839
In Commercial Distribution

  • 00842768019494 ()
  • 00630414640273 ()
10873839

  • Buffered sample diluent IVD

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 Ci-Trol Heparin Control, Low - 00630414640259

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873833
In Commercial Distribution

  • 00842768019548 ()
  • 00630414640259 ()
10873833

  • Multiple coagulation factor IVD, control

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

INNOVANCE D-Dimer Controls - 00630414640181

INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
10873855
In Commercial Distribution

  • 00630414640181 ()
10873855

  • D-dimer IVD, control

Dade Ci-Trol Coagulation Control Level 1 - 00630414640167

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10873842
In Commercial Distribution

  • 00842768019470 ()
  • 00630414640167 ()
10873842

  • Multiple coagulation factor IVD, control

Dade Data-Fi Abnormal Fibrinogen Control - 00630414640150

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10873836
In Commercial Distribution

  • 00842768019524 ()
  • 00630414640150 ()
10873836

  • Fibrinogen assay (factor I) IVD, control

Dade Fibrinogen Determination Reagents - 00630414640105

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873937
In Commercial Distribution

  • 00630414640105 ()
10873937

  • Fibrinogen assay (factor I) IVD, kit, clotting

LA Control High - 00630414640099

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873936
In Commercial Distribution

  • 00842768019685 ()
  • 00630414640099 ()
10873936

  • Lupus anticoagulant marker IVD, control

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
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