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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® D-Dimer - 00842768022814

For the quantitative determination of cross-linked fibrin degradation products (D-dimers) in human plasma on Siemens Sysmex® Coagulation Systems
Siemens Healthcare Diagnostics Products GmbH
10445981
In Commercial Distribution

  • 00842768022814 ()
OPBP09

  • D-dimer IVD, kit, agglutination

N/T Protein Control PY - 00842768021138

Assayed control for Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446656
In Commercial Distribution

  • 00842768021138 ()
  • 00842768018565 ()
OWSY15

  • Plasma protein IVD, control

N Protein Standard PY - 00842768021114

Calibration of Fibrinogen, Antithrombin III, Plasminogen and C1 Inhibitor assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446450
In Commercial Distribution

  • 00842768021114 ()
  • 00842768018732 ()
OUID15

  • Plasma protein IVD, calibrator

Multifibren® U - 00842768017872

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446691
In Commercial Distribution

  • 00842768017872 ()
  • 00842768018503 ()
OWZG23

  • Fibrinogen assay (factor I) IVD, reagent

Multifibren® U - 00842768017865

Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446689
In Commercial Distribution

  • 00842768017865 ()
  • 00842768018541 ()
OWZG19

  • Fibrinogen assay (factor I) IVD, reagent

INNOVANCE Heparin - 00842768017438

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873535
In Commercial Distribution

  • 00842768017438 ()
OPOA05

  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin LMW Control 1 - 00842768017100

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873534
In Commercial Distribution

  • 00842768017100 ()
  • 00630414229539 ()
OPOE05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin LMW Control 2 - 00842768017094

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873533
In Commercial Distribution

  • 00842768017094 ()
  • 00630414229546 ()
OPOF05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 2 - 00842768017087

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873532
In Commercial Distribution

  • 00842768017087 ()
  • 00630414229522 ()
OPOD05

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin UF Control 1 - 00842768017070

For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873531
In Commercial Distribution

  • 00842768017070 ()
  • 00630414229515 ()
OPOC05

  • Heparin anti-Xa IVD, control
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