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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 N Cuvette Segments are part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446539
In Commercial Distribution

  • 00842768012334 ()
  • 00842768024788 ()
OVLK31

  • Laboratory analyser cuvette IVD, single-use
The N Evaporation Cap 5ml is is part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446535
In Commercial Distribution

  • 00842768012303 ()
  • 00842768024801 ()
OVLC31

  • Nephelometry immunoassay analyser IVD
The N Evaporation Cap 2.5ml is part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446534
In Commercial Distribution

  • 00842768012297 ()
  • 00842768024795 ()
OVLC21

  • Nephelometry immunoassay analyser IVD
The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446530
In Commercial Distribution

  • 00842768012259 ()
  • 00842768024979 ()
OVKG03

  • Coagulation analyser IVD, laboratory, semi-automated
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies
Siemens Healthcare Diagnostics Products GmbH
10446499
In Commercial Distribution

  • 00842768011900 ()
OUVV15

  • Protein C IVD, kit, chromogenic
Quantitative determination of retinol-binding protein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446494
In Commercial Distribution

  • 00842768011856 ()
OUVO09

  • Retinol binding protein IVD, kit, nephelometry/turbidimetry
Assayed control used to monitor the performance of coagulation assays in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10446472
In Commercial Distribution

  • 00842768011580 ()
  • 00842768018589 ()
OUPZ19

  • Multiple coagulation factor IVD, control
Calibration of apolipoprotein A-I and B assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446466
In Commercial Distribution

  • 00842768011535 ()
  • 00842768018602 ()
OUPG09

  • Plasma protein IVD, calibrator
Determination of batroxobin time
Siemens Healthcare Diagnostics Products GmbH
10446463
In Commercial Distribution

  • 00842768011504 ()
  • 00842768018725 ()
OUOV21

  • Reptilase time IVD, reagent
Quantitative determination of prealbumin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446452
In Commercial Distribution

  • 00842768011399 ()
OUIF09

  • Collagen pyridium crosslink IVD, reagent
Quantitative determination of ceruloplasmin in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446451
In Commercial Distribution

  • 00842768011382 ()
OUIE09

  • Ceruloplasmin IVD, kit, nephelometry/turbidimetry
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10446445
Not in Commercial Distribution

  • 00842768011337 ()
  • 00842768018749 ()
OUHP49

  • Prothrombin time (PT) IVD, kit, clotting
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10446442
Not in Commercial Distribution

  • 00842768011306 ()
  • 00842768018756 ()
OUHP29

  • Prothrombin time (PT) IVD, kit, clotting
Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy
Siemens Healthcare Diagnostics Products GmbH
10446427
In Commercial Distribution

  • 00842768011160 ()
OUBU15

  • Alpha-2-antiplasmin IVD, kit, chromogenic
Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum
Siemens Healthcare Diagnostics Products GmbH
10285410
Not in Commercial Distribution

  • 00842768011092 ()
OUBA31

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446420
In Commercial Distribution

  • 00842768011085 ()
OUAX41

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Qualitative detection or semi-quantitative determination of C-reactive protein (CRP) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446419
In Commercial Distribution

  • 00842768011078 ()
OUAX31

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Qualitative detection or semi-quantitative determination of rheumatoid factors (RF) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446418
In Commercial Distribution

  • 00842768011061 ()
OUAT45

  • Rheumatoid factor IVD, kit, agglutination
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