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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® Data-Fi® Abnormal Fibrinogen Control - 00842768003936

Assessment of accuracy and precision of Dade® Fibrinogen Determination Reagents in the low range
Siemens Healthcare Diagnostics Products GmbH
10445719
In Commercial Distribution

  • 00842768003936 ()
  • 00842768019524 ()
B4233-22

  • Fibrinogen assay (factor I) IVD, control

Dade® Fibrinogen Determination Reagents - 00842768003929

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445718
Not in Commercial Distribution

  • 00842768003929 ()
B4233-15SY

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

Dade® Ci-Trol® Heparin Control, High - 00842768003905

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445716
In Commercial Distribution

  • 00842768003905 ()
  • 00842768019531 ()
B4224-60

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Heparin Control, Low - 00842768003899

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445715
In Commercial Distribution

  • 00842768003899 ()
  • 00842768019548 ()
B4224-50

  • Multiple coagulation factor IVD, control

Dade® Actin® FSL Activated PTT Reagent - 00842768003875

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
10445713
In Commercial Distribution

  • 00842768003875 ()
  • 00842768019555 ()
B4219-1

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® Activated Cephaloplastin Reagent - 00842768003851

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445711
In Commercial Distribution

  • 00842768003851 ()
  • 00842768019579 ()
B4218-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® Activated Cephaloplastin Reagent - 00842768003837

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445709
In Commercial Distribution

  • 00842768003837 ()
  • 00842768019579 ()
B4218-1

  • Activated partial thromboplastin time (APTT) IVD, reagent

INNOVANCE Free PS Ag - 00842768039522

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
10873458
In Commercial Distribution

  • 00842768039522 ()
OPGL07

  • Protein S IVD, kit, nephelometry/turbidimetry

Dade® CA System Buffer - 00842768039416

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD

BC von Willebrand Reagent - 00842768038211

Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10714565
In Commercial Distribution

  • 00842768038211 ()
  • 00842768018800 ()
OUBD39

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
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