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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 the quantitative measurement of ß2-microglobulin in human serum, plasma and urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445889
In Commercial Distribution

  • 00842768006043 ()
K7024

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445884
In Commercial Distribution

  • 00842768005992 ()
  • 00842768019876 ()
K7014

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry
Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445718
Not in Commercial Distribution

  • 00842768003929 ()
B4233-15SY

  • Fibrinogen assay (factor I) IVD, kit, clotting
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445715
In Commercial Distribution

  • 00842768003899 ()
  • 00842768019548 ()
B4224-50

  • Multiple coagulation factor IVD, control
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445713
In Commercial Distribution

  • 00842768003875 ()
  • 00842768019555 ()
B4219-1

  • Activated partial thromboplastin time (APTT) IVD, reagent
No Description
Siemens Shenzhen Magnetic Resonance Ltd.
11571313
In Commercial Distribution

  • 04056869997933 ()


  • Full-body MRI system, superconducting magnet
No Description
Siemens Shenzhen Magnetic Resonance Ltd.
11571312
In Commercial Distribution

  • 04056869997926 ()


  • Full-body MRI system, superconducting magnet
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11658641
In Commercial Distribution

  • 04056869997445 ()

  • Catheter Gauge: 12.5 French


  • Intracardiac ultrasound imaging catheter, steerable, single-use
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11713176
In Commercial Distribution

  • 04056869996639 ()


  • PET/CT system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11713179
In Commercial Distribution

  • 04056869996622 ()


  • PET/CT system
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