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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
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 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 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 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
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