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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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Berichrom® Heparin LMW Control 2 - 00842768006852

For use as a high level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445988
Not in Commercial Distribution

  • 00842768006852 ()
  • 00842768019203 ()
OPCB03

  • Multiple coagulation factor IVD, control

Berichrom® Heparin LMW Calibrator - 00842768006845

For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin
Siemens Healthcare Diagnostics Products GmbH
10445987
Not in Commercial Distribution

  • 00842768006845 ()
  • 00842768019210 ()
OPCA03

  • Heparin anti-Xa IVD, calibrator

Berichrom® Heparin UF Control 2 - 00842768006838

For use as a high level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445986
Not in Commercial Distribution

  • 00842768006838 ()
  • 00842768019227 ()
OPBZ03

  • Multiple coagulation factor IVD, control

Berichrom® Heparin UF Control 1 - 00842768006821

For use as a low level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin
Siemens Healthcare Diagnostics Products GmbH
10445985
Not in Commercial Distribution

  • 00842768006821 ()
  • 00842768019234 ()
OPBY03

  • Multiple coagulation factor IVD, control

Enzygnost® F1+2 monoclonal - 00842768006760

Quantitative determination of prothrombin fragment F 1+2 in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445978
In Commercial Distribution

  • 00842768006760 ()
OPBD03

  • Prothrombin fragment 1 + 2 IVD, kit, enzyme immunoassay (EIA)

N Latex HCY - 00842768006715

Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445973
In Commercial Distribution

  • 00842768006715 ()
OPAX03

  • Homocysteine IVD, reagent

Protein S Ac - 00842768006678

Determination of the functional activity of protein S in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445968
In Commercial Distribution

  • 00842768006678 ()
OPAP03

  • Protein S IVD, kit, clotting

vWF Ag - 00842768006661

For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10445967
In Commercial Distribution

  • 00842768006661 ()
OPAB03

  • Coagulation factor VIII-associated antigen IVD, kit, nephelometry/turbidimetry

DImension Vista® Protein 2 Calibrator - 00842768006463

For the calibration of ASL, CRP, hsCRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445935
In Commercial Distribution

  • 00842768006463 ()
  • 00842768019296 ()
KC780

  • Plasma protein IVD, calibrator

DImension Vista® Protein 3 Calibrator - 00842768006449

For the calibration of the A1MIC, CYSC, MALB and sALB (for serum, plasma and cerebrospinal fluid) methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445931
In Commercial Distribution

  • 00842768006449 ()
  • 00842768019319 ()
KC770

  • Plasma protein IVD, calibrator
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