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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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INNOVANCE Heparin LMW Control 2 - 00630414639857

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873928
In Commercial Distribution

  • 00630414229546 ()
  • 00630414639857 ()
10873928

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 2 - 00630414639840

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

INNOVANCE Heparin Calibrator - 00630414639833

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873925
In Commercial Distribution

  • 00630414639833 ()
10873925

  • Heparin anti-Xa IVD, calibrator

INNOVANCE Free PS Ag - 00630414639826

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

INNOVANCE Antithrombin - 00630414639796

Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10873911
In Commercial Distribution

  • 00630414639796 ()
10873911

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Standard Human Plasma - 00630414639772

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 - 00630414639765

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

Factor V Leiden - 00630414639758

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

Multifibren U - 00630414639741

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873901
In Commercial Distribution

  • 00842768018503 ()
  • 00630414639741 ()
10873901

  • Fibrinogen assay (factor I) IVD, reagent

Multifibren U - 00630414639734

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873900
In Commercial Distribution

  • 00842768018541 ()
  • 00630414639734 ()
10873900

  • Fibrinogen assay (factor I) IVD, reagent
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