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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Anti-Mullerian Hormone (AMH) - Atellica IM - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205265
In Commercial Distribution

  • 00630414286921 ()
11205265

  • Anti-Mullerian hormone (AMH) IVD, control
Anti-Mullerian Hormone (AMH) - Centaur - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205264
In Commercial Distribution

  • 00630414286914 ()
11205264

  • Anti-Mullerian hormone (AMH) IVD, control
Zika Ab Atellica IM Quality Control Material Kit 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11204648
In Commercial Distribution

  • 00630414286860 ()
11204648

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Zika Ab tellica IM Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
11204647
In Commercial Distribution

  • 00630414286853 ()
11204647

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Zika IgM Atellica IM Quality Control Material Kit 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11204646
In Commercial Distribution

  • 00630414286846 ()
11204646

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Zika IgM Atellica IM Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11204645
In Commercial Distribution

  • 00630414286839 ()
11204645

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases,electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.
Siemens Healthcare Diagnostics Inc.
11416751
In Commercial Distribution

  • 00630414286143 ()
11416751

  • Blood gas/haemoximetry analyser IVD, point-of-care
Erythropoietin (EPO) - Atellica IM - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10733007
In Commercial Distribution

  • 00630414245782 ()
10733007

  • Erythropoietin (EPO) IVD, control
Calcitonin (CALCT) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10733005
In Commercial Distribution

  • 00630414245768 ()
10733005

  • Calcitonin IVD, control
Active-B12 (AB12) QC Kit Atellica IM - CLT 2 x 1 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733002
In Commercial Distribution

  • 00630414245737 ()
10733002

  • Holotranscobalamin (holoTC) IVD, control
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