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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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Her-2/neu (H2n) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995594
In Commercial Distribution

  • 00630414599182 ()
10995594

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Her-2/neu (H2n) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995593
In Commercial Distribution

  • 00630414599175 ()
10995593

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Her-2/neu (H2n) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995592
In Commercial Distribution

  • 00630414599168 ()
  • 00630414190952 ()
10995592

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator
Her-2/neu (H2n) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995591
In Commercial Distribution

  • 00630414599151 ()
10995591

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995590
In Commercial Distribution

  • 00630414599144 ()
10995590

  • Free thyroxine (FT4) IVD, control
Free T4 (FT4) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995589
In Commercial Distribution

  • 00630414599137 ()
10995589

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995588
In Commercial Distribution

  • 00630414599120 ()
  • 00630414007588 ()
10995588

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995586
In Commercial Distribution

  • 00630414599106 ()
10995586

  • Free triiodothyronine (FT3) IVD, control
Free T3 (FT3) Atellica IM - RGT 60T
Siemens Healthcare Diagnostics Inc.
10995585
In Commercial Distribution

  • 00630414599090 ()
10995585

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Free T3 (FT3) Atellica IM - RGT 300T
Siemens Healthcare Diagnostics Inc.
10995584
In Commercial Distribution

  • 00630414599083 ()
  • 00630414007564 ()
10995584

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
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