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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Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995537
In Commercial Distribution

  • 00630414598642 ()
  • 00630414007458 ()
10995537

  • Total cortisol IVD, kit, chemiluminescent immunoassay
CKMB Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995533
In Commercial Distribution

  • 00630414598604 ()
  • 00630414007441 ()
10995533

  • Buffered sample diluent IVD
CKMB Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995531
In Commercial Distribution

  • 00630414598581 ()
  • 00630414007434 ()
10995531

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CHIV QC Kit Atellica IM - CLT 5 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995528
In Commercial Distribution

  • 00630414598550 ()
10995528

  • HIV1/HIV2 antigen/antibody 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
CEA Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
10995524
In Commercial Distribution

  • 00630414598512 ()
  • 00630414007410 ()
10995524

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Calibrator Z - Atellica IM - CAL (2PK) 2 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995521
Not in Commercial Distribution

  • 00630414598482 ()
  • 00630414190921 ()
10995521

  • Digitoxin therapeutic drug monitoring IVD, calibrator
Calibrator U - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995519
In Commercial Distribution

  • 00630414598468 ()
  • 00630414190907 ()
10995519

  • Myoglobin IVD, calibrator
Calibrator O Atellica IM - CAL (2PK) 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995516
In Commercial Distribution

  • 00630414598437 ()
  • 00630414190877 ()
10995516

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator
ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
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