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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 thrombin time in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10446636
In Commercial Distribution

  • 00842768013102 ()
OWNA11

  • Thrombin time (TT) IVD, kit, clotting
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
Determination of heparin activity in plasma and for the monitoring of heparin therapy
Siemens Healthcare Diagnostics Products GmbH
10446620
Not in Commercial Distribution

  • 00842768012945 ()
OWLD11

  • Heparin anti-Xa 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
Quantitative determination of myoglobin in human serun and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446607
In Commercial Distribution

  • 00842768012808 ()
OWIA11

  • Myoglobin 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
Qualitative detection or semi-quantitative determination of rheumatoid factors (RF) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446602
In Commercial Distribution

  • 00842768012754 ()
OWHS21

  • Rheumatoid factor IVD, kit, agglutination
Qualitative detection or semi-quantitative determination of anti-streptolysin O (ASL) in human serum
Siemens Healthcare Diagnostics Products GmbH
10446600
Not in Commercial Distribution

  • 00842768012730 ()
OWHP21

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Determination of thrombin time in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446598
In Commercial Distribution

  • 00842768012716 ()
OWHM13

  • Thrombin time (TT) IVD, kit, clotting
Quantitative determination of Ig light chains, type lambda in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446597
In Commercial Distribution

  • 00842768012709 ()
OWHH13

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Quantitative determination of Ig light chains, type kappa in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446595
In Commercial Distribution

  • 00842768012686 ()
OWHG13

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446541
In Commercial Distribution

  • 00842768012358 ()
  • 00842768025006 ()
OVMN11

  • Coagulation analyser IVD, laboratory, semi-automated
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
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
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