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 Class Implantable

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Dimension® EXL™ with LM integrated chemistry system with Reagent Management System (RMS)
Siemens Healthcare Diagnostics Inc.
10475506
In Commercial Distribution

  • 00630414014128 ()
778020.911

  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Siemens Healthcare Diagnostics Inc.
10995083
In Commercial Distribution

  • 00630414010472 ()
10995083

  • Interleukin-6 (IL-6) IVD, control
ADVIA Centaur ® IL-6 100T Kit
Siemens Healthcare Diagnostics Inc.
10995080
In Commercial Distribution

  • 00630414010434 ()
10995080

  • Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay
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
Erythropoietin (EPO) - ADVIA Centaur - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995096
In Commercial Distribution

  • 00630414010380 ()
10995096

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
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
Aspartate Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097639
In Commercial Distribution

  • 00630414009063 ()
11097639

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T
Siemens Healthcare Diagnostics Inc.
11097638
In Commercial Distribution

  • 00630414009056 ()
11097638

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
6 vials of 1 calibrator level
Siemens Healthcare Diagnostics Inc.
10916059
In Commercial Distribution

  • 00630414008981 ()
10916059

  • Total creatine kinase (CK) IVD, calibrator
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