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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 Size Device Size Type Device Class Implantable

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Atellica IM aTG DIL - 00630414597904

TG Ab Ancillary Diluent - Atellica IM - CONS - 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995463
In Commercial Distribution

  • 00630414597904 ()
  • 00630414007304 ()
10995463

  • Buffered sample diluent IVD

Atellica IM aTG - 00630414597898

TG Ab - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995462
In Commercial Distribution

  • 00630414597898 ()
  • 00630414007298 ()
10995462

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Atellica IM aTG - 00630414597881

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

  • 00630414597881 ()
10995461

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Atellica™ IM aHCV QC - 00630414597874

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

Atellica™ IM aHCV - 00630414597867

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

Atellica™ IM aHBs2 QC - 00630414597843

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

Atellica™ IM aHBs2 - 00630414597836

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

Atellica™ IM aHBcM QC - 00630414597805

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

Atellica™ IM aHBcM - 00630414597799

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

Atellica IM aHAVT QC - 00630414597775

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
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