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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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The Stratus® CS Acute Care(TM) NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma and is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445086
In Commercial Distribution

  • 00842768019715 ()
  • 00630414009964 ()
CPBNPM

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
IRON Calibrator, 2x2x1.2mL
Siemens Healthcare Diagnostics Inc.
10445010
In Commercial Distribution

  • 00842768019616 ()
DC85

  • Iron IVD, calibrator
Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445997
In Commercial Distribution

  • 00842768018534 ()
OPCS05

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
Total Bilirubin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444938
Not in Commercial Distribution

  • 00842768018312 ()
  • 00630414004259 ()
DF107

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Mass Creatine Kinase MB Isoenzyme Calibrator, 2x4x1mL / 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10445195
In Commercial Distribution

  • 00842768017919 ()
KC672

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446691
In Commercial Distribution

  • 00842768017872 ()
  • 00842768018503 ()
OWZG23

  • Fibrinogen assay (factor I) IVD, reagent
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10446689
In Commercial Distribution

  • 00842768017865 ()
  • 00842768018541 ()
OWZG19

  • Fibrinogen assay (factor I) IVD, reagent
Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagulation analyzers
Siemens Healthcare Diagnostics Products GmbH
10446684
In Commercial Distribution

  • 00842768017742 ()
  • 00842768020308 ()
OWZC39

  • Multiple coagulation factor IVD, reagent
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
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