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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 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

Dade Innovin - 00630414640006

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873933
In Commercial Distribution

  • 00842768019586 ()
  • 00630414640006 ()
10873933

  • Prothrombin time (PT) IVD, reagent

Thromborel S - 00630414639963

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873931
In Commercial Distribution

  • 00842768018749 ()
  • 00630414639963 ()
10873931

  • Prothrombin time (PT) IVD, reagent

INNOVANCE Heparin LMW Control 1 - 00630414639956

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873929
In Commercial Distribution

  • 00630414229539 ()
  • 00630414639956 ()
10873929

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00630414639949

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873926
In Commercial Distribution

  • 00630414229515 ()
  • 00630414639949 ()
10873926

  • Heparin anti-Xa IVD, control

Dade CA System Buffer - 00630414639901

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873915
In Commercial Distribution

  • 00842768019845 ()
  • 00630414639901 ()
10873915

  • Buffered sample diluent IVD

Dade Innovin - 00630414639888

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873934
In Commercial Distribution

  • 00842768019609 ()
  • 00630414639888 ()
10873934

  • Prothrombin time (PT) IVD, reagent

Dade Innovin - 00630414639871

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873932
In Commercial Distribution

  • 00842768019593 ()
  • 00630414639871 ()
10873932

  • Prothrombin time (PT) IVD, reagent
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