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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For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445706
Not in Commercial Distribution

  • 00842768003806 ()
  • 00842768019586 ()
B4212-50

  • Prothrombin time (PT) IVD, reagent
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445705
Not in Commercial Distribution

  • 00842768003790 ()
  • 00842768019593 ()
B4212-40

  • Prothrombin time (PT) IVD, reagent
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445704
Not in Commercial Distribution

  • 00842768003783 ()
  • 00842768019609 ()
B4212-100

  • Prothrombin time (PT) IVD, reagent
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
The N-cuvettessegment is an consumable in the BNII system.
Siemens Healthcare Diagnostics Products GmbH
10446520
In Commercial Distribution

  • 00842768012167 ()
  • 00842768024771 ()
OVIB31

  • Nephelometry immunoassay analyser IVD
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10446500
In Commercial Distribution

  • 00842768011917 ()
OUVV17

  • Protein C IVD, kit, chromogenic
Quantitative determination of hemopexin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446493
In Commercial Distribution

  • 00842768011849 ()
OUVN09

  • Haemopexin IVD, reagent
Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
Siemens Healthcare Diagnostics Products GmbH
10446431
In Commercial Distribution

  • 00842768011207 ()
OUCA17

  • Plasminogen IVD, kit, chromogenic
Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446422
Not in Commercial Distribution

  • 00842768011108 ()
OUBA43

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Qualitative detection or semi-quantitative determination of rheumatoid factors (RF) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446417
In Commercial Distribution

  • 00842768011054 ()
OUAT35

  • Rheumatoid factor IVD, kit, agglutination
For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446414
In Commercial Distribution

  • 00842768011023 ()
  • 00842768018824 ()
OTXX17

  • Coagulation factor IX IVD, reagent
For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446411
In Commercial Distribution

  • 00842768010996 ()
  • 00842768018831 ()
OTXW17

  • Coagulation factor VIII IVD, reagent
For the determination of the activity of coagulation factor VII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446407
In Commercial Distribution

  • 00842768010958 ()
  • 00842768018848 ()
OTXV13

  • Coagulation factor VII IVD, reagent
For the determination of the activity of coagulation factor II (prothrombin) in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446330
In Commercial Distribution

  • 00842768010156 ()
  • 00842768018855 ()
OSGR13

  • Coagulation factor II (prothrombin) IVD, reagent
For the determination of the activity of coagulation factor XII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446318
In Commercial Distribution

  • 00842768009990 ()
  • 00842768018862 ()
OSDG13

  • Coagulation factor XII IVD, reagent
For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446316
In Commercial Distribution

  • 00842768009976 ()
  • 00842768018879 ()
OSDF13

  • Coagulation factor XI IVD, reagent
Quantitative determination of plasminogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446314
In Commercial Distribution

  • 00842768009952 ()
OSCB09

  • Plasminogen IVD, reagent
Quantitative determination of fibrinogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446313
In Commercial Distribution

  • 00842768009945 ()
OSCA09

  • Fibrinogen assay (factor I) IVD, kit, clotting
Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446312
In Commercial Distribution

  • 00842768009938 ()
OSAZ15

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry
Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446311
In Commercial Distribution

  • 00842768009921 ()
OSAZ09

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry
Quantitative determination of antithrombin III in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446310
In Commercial Distribution

  • 00842768009914 ()
OSAY09

  • Antithrombin III (ATIII) IVD, reagent
Quantitative determination of transferrin in human serum, plasma and urine on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446308
In Commercial Distribution

  • 00842768009891 ()
OSAX09

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446306
In Commercial Distribution

  • 00842768009877 ()
OSAW09

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446305
In Commercial Distribution

  • 00842768009860 ()
OSAV15

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of haptoglobin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446304
In Commercial Distribution

  • 00842768009853 ()
OSAV09

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446303
In Commercial Distribution

  • 00842768009846 ()
OSAT19

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446301
In Commercial Distribution

  • 00842768009822 ()
OSAT11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446299
In Commercial Distribution

  • 00842768009808 ()
OSAS19

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgG in human serum, plasma and CSF on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446297
In Commercial Distribution

  • 00842768009785 ()
OSAS11

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446295
In Commercial Distribution

  • 00842768009761 ()
OSAR19

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446293
In Commercial Distribution

  • 00842768009747 ()
OSAR11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of complement C3/C3c in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446291
In Commercial Distribution

  • 00842768009723 ()
OSAP15

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
Quantitative determination of complement C3/C3c in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446290
In Commercial Distribution

  • 00842768009716 ()
OSAP09

  • Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
Quantitative determination of complement C4 in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446289
In Commercial Distribution

  • 00842768009709 ()
OSAO15

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
Quantitative determination of complement C4 in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446288
In Commercial Distribution

  • 00842768009693 ()
OSAO09

  • Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446287
In Commercial Distribution

  • 00842768009686 ()
OSAN15

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446286
In Commercial Distribution

  • 00842768009679 ()
OSAN09

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446271
In Commercial Distribution

  • 00842768009525 ()
  • 00842768018886 ()
ORSM23

  • Coagulation factor V IVD, reagent
Assayed control used to monitor the performance of coagulation assays in the normal range
Siemens Healthcare Diagnostics Products GmbH
10446235
In Commercial Distribution

  • 00842768009174 ()
  • 00842768018909 ()
ORKE45

  • Multiple coagulation factor IVD, control
Coagulation test for the quantitative determination of protein C activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446185
In Commercial Distribution

  • 00842768008641 ()
OQYG11

  • Protein C IVD, kit, clotting
Quantitative determination of IgG subclass 2 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446169
In Commercial Distribution

  • 00842768008467 ()
OQXK09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
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