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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Sex Hormone Binding Globulin (SHBG) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995672
In Commercial Distribution

  • 00630414599854 ()
10995672

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Rubella IgM (Rub M) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995669
In Commercial Distribution

  • 00630414599847 ()
10995669

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
Rubella IgM (Rub M) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995668
In Commercial Distribution

  • 00630414599830 ()
10995668

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995664
In Commercial Distribution

  • 00630414599823 ()
10995664

  • Total prostate specific antigen (tPSA) IVD, control
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995663
In Commercial Distribution

  • 00630414599816 ()
  • 00630414007755 ()
10995663

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995662
In Commercial Distribution

  • 00630414599809 ()
10995662

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Progesterone (PRGE) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995661
In Commercial Distribution

  • 00630414599793 ()
10995661

  • Progesterone IVD, control
Progesterone (PRGE) Atellica IM - RGT 90T
Siemens Healthcare Diagnostics Inc.
10995660
In Commercial Distribution

  • 00630414599786 ()
10995660

  • Progesterone IVD, kit, chemiluminescent immunoassay
Progesterone (PRGE) Atellica IM - RGT 450T
Siemens Healthcare Diagnostics Inc.
10995659
In Commercial Distribution

  • 00630414599779 ()
10995659

  • Progesterone IVD, kit, chemiluminescent immunoassay
Prolactin (PRL) Atellica IM - Master Curve Material Kit 9x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995657
In Commercial Distribution

  • 00630414599755 ()
10995657

  • Prolactin IVD, control
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