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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 2 - 00842768004063

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445732
In Commercial Distribution

  • 00842768004063 ()
  • 00842768019463 ()
B4244-20

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Coagulation Control Level 1 - 00842768004056

For use as control in citrated coagulation systems
Siemens Healthcare Diagnostics Products GmbH
10445731
In Commercial Distribution

  • 00842768004056 ()
  • 00842768019470 ()
B4244-10

  • Multiple coagulation factor IVD, control

Dade® Hepzyme® - 00842768004049

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445730
In Commercial Distribution

  • 00842768004049 ()
  • 00842768019487 ()
B4240-10

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00842768004032

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445729
In Commercial Distribution

  • 00842768004032 ()
B4238-40

  • Coagulation factor VIII IVD, kit, chromogenic

Dade® Cluster® Platelet Aggregation Reagents - 00842768003998

For use in platelet aggregometry studies
Siemens Healthcare Diagnostics Products GmbH
10445725
In Commercial Distribution

  • 00842768003998 ()
B4236-1

  • Platelet aggregation study IVD, kit, nephelometry/turbidimetry

Dade® Owren's Veronal Buffer - 00842768003981

Dilution buffer for coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10445724
In Commercial Distribution

  • 00842768003981 ()
  • 00842768019494 ()
B4234-25

  • Buffered sample diluent IVD

Dade® DIMERTEST® Latex Beads - 00842768003974

For use with DIMERTEST® Latex kit for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445723
Not in Commercial Distribution

  • 00842768003974 ()
B4233-61L

  • D-dimer IVD, reagent

Dade® DIMERTEST® Latex Assay - 00842768003967

The DIMERTEST® Latex Assay is intended for the rapid qualitative or semiquantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445722
Not in Commercial Distribution

  • 00842768003967 ()
B4233-60

  • D-dimer IVD, kit, agglutination

Dade® Thrombin Reagent - 00842768003950

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445721
In Commercial Distribution

  • 00842768003950 ()
  • 00842768019500 ()
B4233-27

  • Fibrinogen assay (factor I) IVD, reagent

Dade® Thrombin Reagent - 00842768003943

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10445720
In Commercial Distribution

  • 00842768003943 ()
  • 00842768019517 ()
B4233-25

  • Fibrinogen assay (factor I) IVD, reagent
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