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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HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995450
In Commercial Distribution

  • 00630414597805 ()
10995450

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995449
In Commercial Distribution

  • 00630414597799 ()
10995449

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995444
In Commercial Distribution

  • 00630414597737 ()
10995444

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
RBC Folate - Atellica IM - CONS - 4 x 30mL
Siemens Healthcare Diagnostics Inc.
10995440
In Commercial Distribution

  • 00630414597690 ()
  • 00630414190600 ()
10995440

  • Dithiothriotol (DTT) reagent IVD
Urinary Total Protein (UPro) Calibrator Atellica CH - CAL 3 x 5.0mL
Siemens Healthcare Diagnostics Inc.
11099441
Not in Commercial Distribution

  • 00630414597621 ()
  • 00630414007168 ()
11099441

  • Total protein IVD, calibrator
TDM Calibrator Atellica CH - CAL 5 x 2 x 3.0mL
Siemens Healthcare Diagnostics Inc.
11099439
In Commercial Distribution

  • 00630414597607 ()
11099439

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator
Alanine Aminotransferase P5P (ALTP5P) Atellica CH - RGT 1684T
Siemens Healthcare Diagnostics Inc.
11097598
In Commercial Distribution

  • 00630414596433 ()
11097598

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Aspartate Aminotransferase P5P (ASTP5P) - Atellica™ CH - RGT - 1684T
Siemens Healthcare Diagnostics Inc.
11097599
In Commercial Distribution

  • 00630414596426 ()
11097599

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Alkaline Phosphatase, Concentrated (ALP_2c) Atellica CH - Rgt 4800T
Siemens Healthcare Diagnostics Inc.
11097600
In Commercial Distribution

  • 00630414596419 ()
11097600

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Iron (Iron_2) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097601
In Commercial Distribution

  • 00630414596402 ()
11097601

  • Iron IVD, kit, spectrophotometry
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