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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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Assayed control for IgG, IgA, Transferrin, Albumin, a1-microglobulin and Total protein assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446105
In Commercial Distribution

  • 00842768007859 ()
  • 00842768018961 ()
OQLW15

  • Plasma protein IVD, control
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
Washing Solution (concentrate) for cleaning the cuvettes in the BN II System
Siemens Healthcare Diagnostics Products GmbH
10446098
In Commercial Distribution

  • 00842768007781 ()
  • 00842768018992 ()
OQKY61

  • Buffered wash solution IVD
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
Determination of the activated partial thromboplastin time (APTT) in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446066
In Commercial Distribution

  • 00842768007521 ()
  • 00842768019074 ()
OQGS29

  • Activated partial thromboplastin time (APTT) IVD, reagent
LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10458687
In Commercial Distribution

  • 00842768007491 ()
  • 00842768019661 ()
OQGR11

  • Lupus anticoagulant marker IVD, reagent
LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10461887
In Commercial Distribution

  • 00842768007477 ()
  • 00842768019654 ()
OQGP15

  • Lupus anticoagulant marker IVD, reagent
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