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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 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 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
10446442
Not in Commercial Distribution

  • 00842768011306 ()
  • 00842768018756 ()
OUHP29

  • Prothrombin time (PT) IVD, kit, clotting
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
For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446411
In Commercial Distribution

  • 00842768010996 ()
  • 00842768018831 ()
OTXW17

  • Coagulation factor VIII IVD, reagent
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