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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HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
Siemens Healthcare Diagnostics Inc.
10995603
In Commercial Distribution

  • 00630414599267 ()
10995603

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
10995600
In Commercial Distribution

  • 00630414599236 ()
10995600

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995599
In Commercial Distribution

  • 00630414599229 ()
10995599

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control
HBC Total Ab (HBcT) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995598
In Commercial Distribution

  • 00630414599212 ()
10995598

  • Hepatitis B virus core total antibody IVD, control
HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995597
In Commercial Distribution

  • 00630414599205 ()
10995597

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
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
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