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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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
Cyclosporine (CsA) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995549
In Commercial Distribution

  • 00630414598734 ()
  • 00842768027383 ()
10995549

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Cyclosporine (CsA) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995548
In Commercial Distribution

  • 00630414598727 ()
10995548

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Complexed Prostate Specific Antigen (cPSA) QC Kit - Atellica IM - CLT 3 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995547
In Commercial Distribution

  • 00630414598710 ()
10995547

  • Complexed prostate specific antigen (cPSA) 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
Cortisol Urine Reconstitution Buffer Atellica IM - CONS 1 x 60mL
Siemens Healthcare Diagnostics Inc.
10995540
In Commercial Distribution

  • 00630414598673 ()
10995540

  • Total cortisol IVD, reagent
Cortisol - Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995538
In Commercial Distribution

  • 00630414598659 ()
10995538

  • Total cortisol IVD, kit, chemiluminescent immunoassay
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
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