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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TG Ab - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995461
In Commercial Distribution

  • 00630414597881 ()
10995461

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
HCV (aHCV) QC Kit - Atellica IM - CLT 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995457
In Commercial Distribution

  • 00630414597874 ()
10995457

  • Hepatitis C virus total antibody IVD, control
HCV (aHCV) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995456
In Commercial Distribution

  • 00630414597867 ()
10995456

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Anti-HBs2 (aHBs2) QC Kit - Atellica IM - CLT 2 x 2 x 10.0 mL
Siemens Healthcare Diagnostics Inc.
10995454
In Commercial Distribution

  • 00630414597843 ()
10995454

  • Hepatitis B virus surface total antibody IVD, control
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995453
In Commercial Distribution

  • 00630414597836 ()
10995453

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
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
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 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
Albumin BCG (Alb) Atellica CH - RGT 6800T
Siemens Healthcare Diagnostics Inc.
11097590
In Commercial Distribution

  • 00630414596501 ()
  • 00630414007182 ()
11097590

  • Albumin IVD, kit, nephelometry/turbidimetry
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