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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 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
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
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 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
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 X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446415
In Commercial Distribution

  • 00842768011030 ()
  • 00842768018817 ()
OTXY13

  • Coagulation factor X IVD, reagent
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
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