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 Class Implantable

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Estradiol (eE2) Atellica IM RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995562
In Commercial Distribution

  • 00630414598864 ()
10995562

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Estradiol (eE2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995561
In Commercial Distribution

  • 00630414598857 ()
10995561

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Digoxin (Dig) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995559
In Commercial Distribution

  • 00630414598833 ()
10995559

  • Digoxin therapeutic drug monitoring IVD, control
DHEAS - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995556
In Commercial Distribution

  • 00630414598802 ()
10995556

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
DHEAS - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995555
In Commercial Distribution

  • 00630414598796 ()
10995555

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995551
In Commercial Distribution

  • 00630414598758 ()
10995551

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Complexed Prostate Specific Antigen (cPSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995545
In Commercial Distribution

  • 00630414598697 ()
10995545

  • Complexed prostate specific antigen (cPSA) IVD, control
CKMB - Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995534
In Commercial Distribution

  • 00630414598611 ()
10995534

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, control
CEA - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995526
In Commercial Distribution

  • 00630414598536 ()
10995526

  • Carcinoembryonic antigen (CEA) IVD, control
Calibrator B - Atellica IM CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995504
In Commercial Distribution

  • 00630414598314 ()
  • 00630414190778 ()
10995504

  • Multiple human hormone IVD, calibrator
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