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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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Enzygnost® TAT micro - 00842768013065

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

N a1-Microglobulin Kit - 00842768012938

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

RapiTex® CRP - 00842768012778

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 - 00842768012198

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

N Predilution Wells - 00842768012174

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

N Cuvette Segments for BN II - 00842768012167

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

Berichrom® Protein C - 00842768011917

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

N Antiserum to Human Hemopexin - 00842768011849

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

Berichrom® Plasminogen - 00842768011207

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

RapiTex® ASL - 00842768011108

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
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