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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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Quantitative determination of IgE in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446129
In Commercial Distribution

  • 00842768008078 ()
  • 00842768018947 ()
OQTG15

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry
Supplementary reagent for multiple protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446128
In Commercial Distribution

  • 00842768008061 ()
OQTD11

  • Immunoglobulin removal reagent IVD
Quantitative determination of soluble transferrin receptor (sTfR) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446127
In Commercial Distribution

  • 00842768008054 ()
  • 00842768018954 ()
OQTC11

  • Soluble transferrin receptor IVD, reagent
Check of the proper functioning and precision of the pipettors on the BCS® System, the BCS® XP System and the BCT System
Siemens Healthcare Diagnostics Products GmbH
10446125
In Commercial Distribution

  • 00842768008023 ()
OQSC11

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
Quantitative determination of cystatin C in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446116
In Commercial Distribution

  • 00842768007934 ()
OQNM13

  • Cystatin C IVD, kit, nephelometry/turbidimetry
Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446103
In Commercial Distribution

  • 00842768007835 ()
  • 00842768018978 ()
OQLV09

  • Plasma protein IVD, calibrator
Assayed control to monitor the performance of Factor V Leiden assay in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10446097
In Commercial Distribution

  • 00842768007774 ()
  • 00842768019005 ()
OQKE19

  • Protein C IVD, control
N Protein Standard SL is a multi-analyte calibrator for the establishment of reference curves on the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446073
In Commercial Distribution

  • 00842768007590 ()
  • 00842768019050 ()
OQIM13

  • Plasma protein IVD, calibrator
Quantitative determination of Lp(a) in human serum and heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446069
In Commercial Distribution

  • 00842768007552 ()
  • 00842768019067 ()
OQHL11

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446067
In Commercial Distribution

  • 00842768007538 ()
  • 00842768019074 ()
OQGS35

  • Activated partial thromboplastin time (APTT) IVD, reagent
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