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

  • 00842768019494 ()
  • 00630414640273 ()
10873839

  • Buffered sample diluent IVD
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10873833
In Commercial Distribution

  • 00842768019548 ()
  • 00630414640259 ()
10873833

  • Multiple coagulation factor IVD, control
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
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
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
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 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
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873927
In Commercial Distribution

  • 00630414229522 ()
  • 00630414639840 ()
10873927

  • Heparin anti-Xa IVD, control
For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.
Siemens Healthcare Diagnostics Products GmbH
10873921
In Commercial Distribution

  • 00630414639826 ()
10873921

  • Protein S IVD, kit, nephelometry/turbidimetry
Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10873907
In Commercial Distribution

  • 00842768018893 ()
  • 00630414639772 ()
10873907

  • Multiple coagulation factor IVD, calibrator
LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873904
In Commercial Distribution

  • 00842768019654 ()
  • 00630414639765 ()
10873904

  • Lupus anticoagulant marker IVD, reagent
Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect
Siemens Healthcare Diagnostics Products GmbH
10873903
In Commercial Distribution

  • 00630414639758 ()
10873903

  • Activated protein C resistance ratio (APCR) IVD, kit, clotting
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873901
In Commercial Distribution

  • 00842768018503 ()
  • 00630414639741 ()
10873901

  • Fibrinogen assay (factor I) IVD, reagent
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873900
In Commercial Distribution

  • 00842768018541 ()
  • 00630414639734 ()
10873900

  • Fibrinogen assay (factor I) IVD, reagent
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10873893
In Commercial Distribution

  • 00630414639710 ()
10873893

  • Protein C IVD, kit, chromogenic
Assayed control used to monitor the performance of coagulation assays in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10873891
In Commercial Distribution

  • 00842768018589 ()
  • 00630414639703 ()
10873891

  • Multiple coagulation factor IVD, control
Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873910
In Commercial Distribution

  • 00630414639680 ()
10873910

  • Antithrombin III (ATIII) IVD, kit, chromogenic
Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873909
In Commercial Distribution

  • 00630414639673 ()
10873909

  • Antithrombin III (ATIII) IVD, kit, chromogenic
For use in conjunction with INNOVANCE D-Dimer to dilute samples
Siemens Healthcare Diagnostics Products GmbH
10873905
In Commercial Distribution

  • 00842768019265 ()
  • 00630414639666 ()
10873905

  • Buffered sample diluent IVD
Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873899
In Commercial Distribution

  • 00630414639659 ()
10873899

  • Antithrombin III (ATIII) IVD, kit, chromogenic
Determination of thrombin time in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873894
In Commercial Distribution

  • 00630414639635 ()
10873894

  • Thrombin time (TT) IVD, kit, clotting
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10873892
In Commercial Distribution

  • 00630414639628 ()
10873892

  • Protein C IVD, kit, chromogenic
Determination of batroxobin time
Siemens Healthcare Diagnostics Products GmbH
10873889
In Commercial Distribution

  • 00842768018725 ()
  • 00630414639611 ()
10873889

  • Reptilase time IVD, reagent
For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873883
In Commercial Distribution

  • 00842768018879 ()
  • 00630414639604 ()
10873883

  • Coagulation factor XI IVD, reagent
For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873882
In Commercial Distribution

  • 00842768018817 ()
  • 00630414639598 ()
10873882

  • Coagulation factor X IVD, reagent
For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873906
In Commercial Distribution

  • 00630414639468 ()
10873906

  • von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry
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