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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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To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445701
In Commercial Distribution

  • 00842768003691 ()
  • 00842768019791 ()
B4170-50

  • Platelet aggregation study IVD, reagent
To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445699
In Commercial Distribution

  • 00842768003684 ()
  • 00842768019784 ()
B4170-21A

  • Platelet aggregation study IVD, reagent
To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445697
In Commercial Distribution

  • 00842768003660 ()
  • 00842768019777 ()
B4170-20A

  • Platelet aggregation study IVD, reagent
Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10446232
In Commercial Distribution

  • 00842768014222 ()
  • 00842768018916 ()
ORHO37

  • Calcium chloride coagulation reagent IVD
Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446658
In Commercial Distribution

  • 00842768013317 ()
OWTI11

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent
Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446632
In Commercial Distribution

  • 00842768013065 ()
OWMG15

  • Coagulation factor VIII IVD, kit, chromogenic
Quantitative determination of a1-microglobulin in human urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446619
In Commercial Distribution

  • 00842768012938 ()
OWLA11

  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry
Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446604
In Commercial Distribution

  • 00842768012778 ()
OWHU21

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Behring Coagulation Cup serves as vessel for samples, human plasma and buffer solutions.
Siemens Healthcare Diagnostics Products GmbH
10446526
In Commercial Distribution

  • 00842768012198 ()
  • 00842768024757 ()
OVIS31

  • Coagulation analyser IVD, laboratory
The N Predilution Well is used for settings of dilutions of standards, controls and sera.
Siemens Healthcare Diagnostics Products GmbH
10446521
In Commercial Distribution

  • 00842768012174 ()
  • 00842768024764 ()
OVIC11

  • Assay container IVD, single-use
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