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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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
Digoxin (Dig) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995558
In Commercial Distribution

  • 00630414598826 ()
10995558

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Digoxin (Dig) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995557
In Commercial Distribution

  • 00630414598819 ()
  • 00630414007496 ()
10995557

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
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
Digitoxin (Dgtn) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995554
Not in Commercial Distribution

  • 00630414598789 ()
10995554

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Digitoxin (Dgtn) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995553
Not in Commercial Distribution

  • 00630414598772 ()
  • 00630414007489 ()
10995553

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Siemens Healthcare Diagnostics Inc.
10995552
In Commercial Distribution

  • 00630414598765 ()
  • 00630414007465 ()
10995552

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
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