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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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For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873567
In Commercial Distribution

  • 00630414023489 ()
  • 00842768019586 ()
B4212-51

  • Prothrombin time (PT) IVD, reagent
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873566
In Commercial Distribution

  • 00630414023472 ()
  • 00842768019593 ()
B4212-41

  • Prothrombin time (PT) IVD, reagent
Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873564
Not in Commercial Distribution

  • 00630414023441 ()
  • 00842768018756 ()
OUHP31

  • Prothrombin time (PT) IVD, kit, clotting
Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10998577
Not in Commercial Distribution

  • 00630414022963 ()
10998577

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITHOUT AUTOSAMPLER
Siemens Healthcare Diagnostics Inc.
11219531
In Commercial Distribution

  • 00630414019796 ()
11219531

  • Haematological cell analyser IVD
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH SINGLE ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219530
In Commercial Distribution

  • 00630414019789 ()
11219530

  • Haematological cell analyser IVD
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH DUAL ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219529
In Commercial Distribution

  • 00630414019772 ()
11219529

  • Haematological cell analyser IVD
Herpes-1 IgG (HSV1) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720847
In Commercial Distribution

  • 00630414016757 ()
10720847

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720846
In Commercial Distribution

  • 00630414016740 ()
10720846

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720850
In Commercial Distribution

  • 00630414016733 ()
10720850

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
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