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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HAV Total (HAVT) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995447
In Commercial Distribution

  • 00630414597775 ()
10995447

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995596
In Commercial Distribution

  • 00630414597768 ()
10995596

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10995445
In Commercial Distribution

  • 00630414597744 ()
10995445

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
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
Alpha-Fetoprotein(AFP) - Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995443
In Commercial Distribution

  • 00630414597720 ()
10995443

  • Alpha-fetoprotein (AFP) IVD, control
RBC Folate - Atellica IM - CONS - 4 x 30mL
Siemens Healthcare Diagnostics Inc.
10995440
In Commercial Distribution

  • 00630414597690 ()
  • 00630414190600 ()
10995440

  • Dithiothriotol (DTT) reagent IVD
ß2-Microglobulin (B2M) Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099442
In Commercial Distribution

  • 00630414597638 ()
  • 00630414007175 ()
11099442

  • Beta-2-microglobulin IVD, calibrator
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
Toxicology (TOX) Calibrator Atellica CH - CAL 5 x 2 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099440
In Commercial Distribution

  • 00630414597614 ()
  • 00630414007090 ()
11099440

  • Multiple-type clinical chemistry analyte profile 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
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