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 Class Implantable

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Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10995099
In Commercial Distribution

  • 00630414010403 ()
10995099

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10995098
In Commercial Distribution

  • 00630414010397 ()
10995098

  • Erythropoietin (EPO) IVD, control
Calcitonin (CALCT) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995094
In Commercial Distribution

  • 00630414010373 ()
10995094

  • Calcitonin IVD, control
Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097638
In Commercial Distribution

  • 00630414009056 ()
11097638

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Atellica IM 1300 Analyzer
Siemens Healthcare Diagnostics Inc.
11066001
In Commercial Distribution

  • 00630414007960 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
High Sensitivity Troponin I (TnIH) Atellica IM Master Curve Material Kit 5 X 1.0ml
Siemens Healthcare Diagnostics Inc.
10997842
In Commercial Distribution

  • 00630414006772 ()
10997842

  • Troponin I IVD, control
Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL
Siemens Healthcare Diagnostics Inc.
11099406
Not in Commercial Distribution

  • 00630414002699 ()
  • 00630414211572 ()
11099406

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Atellica SAMPLE HANDLER ADDITIONAL MODULE
Siemens Healthcare Diagnostics Inc.
11069004
In Commercial Distribution

  • 00630414002460 ()
11069004

  • Specimen processing instrument IVD
Atellica SAMPLE HANDLER PRIMARY MODULE
Siemens Healthcare Diagnostics Inc.
11069001
In Commercial Distribution

  • 00630414002439 ()
11069001

  • Specimen processing instrument IVD
Atellica DL PRIMARY KIT
Siemens Healthcare Diagnostics Inc.
11068009
In Commercial Distribution

  • 00630414002354 ()
11068009

  • Specimen processing instrument IVD
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