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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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Luteinizing Hormone (LH) Atellica IM - RGT - 110T
Siemens Healthcare Diagnostics Inc.
10995635
In Commercial Distribution

  • 00630414599533 ()
10995635

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Intact parathyroid hormone (iPTH) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995626
In Commercial Distribution

  • 00630414599496 ()
10995626

  • Parathyroid hormone (PTH) IVD, control
Total IgE (tIgE) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995617
In Commercial Distribution

  • 00630414599403 ()
10995617

  • Total immunoglobulin E (IgE total) IVD, control
Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995609
In Commercial Distribution

  • 00630414599328 ()
10995609

  • Homocysteine 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
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
Follicle Stimulating Hormone (FSH) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995582
In Commercial Distribution

  • 00630414599069 ()
10995582

  • Follicle stimulating hormone (FSH) IVD, control
Follicle Stimulating Hormone (FSH) Atellica IM - RGT 950T
Siemens Healthcare Diagnostics Inc.
10995581
In Commercial Distribution

  • 00630414599052 ()
  • 00630414007557 ()
10995581

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Follicle Stimulating Hormone (FSH) Atellica IM - RGT 190T
Siemens Healthcare Diagnostics Inc.
10995580
In Commercial Distribution

  • 00630414599045 ()
10995580

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Folic Acid (Fol) - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995575
In Commercial Distribution

  • 00630414598994 ()
10995575

  • Folate (vitamin B9) IVD, control
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