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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 Size Type Device Class Implantable

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ADVIA Centaur® TSTO - 00630414235271

ADVIA Centaur® Testosterone (TSTO) Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11201912
Not in Commercial Distribution

  • 00630414235271 ()
11201912

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Dimension Vista ECREA CAL - 00630414235103

Dimension Vista ECREA CAL
Siemens Healthcare Diagnostics Inc.
11349584
In Commercial Distribution

  • 00630414235103 ()
KC270A

  • Creatinine IVD, calibrator

Dimension Vista CHEM 1 CAL - 00630414235097

Dimension Vista CHEM 1 CAL
Siemens Healthcare Diagnostics Inc.
11349583
In Commercial Distribution

  • 00630414235097 ()
KC110C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica IM VitD - 00630414234489

Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11201773
In Commercial Distribution

  • 00630414234489 ()
11201773

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Atellica IM VitD - 00630414234472

Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11201772
In Commercial Distribution

  • 00630414234472 ()
11201772

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Syva Emit II Plus 6-Acetylmorphine Assay - 00630414229591

Syva Emit II Plus 6-Acetylmorphine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10730975
In Commercial Distribution

  • 00630414229591 ()
9R029UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Atellica CI Rack Handler - 00630414229560

Atellica CI Rack Handler
Siemens Healthcare Diagnostics Inc.
10947348
In Commercial Distribution

  • 00630414229560 ()
10947348

  • Specimen processing instrument IVD

Atellica CI Analyzer - 00630414229553

Atellica CI Analyzer
Siemens Healthcare Diagnostics Inc.
10947347
In Commercial Distribution

  • 00630414229553 ()
10947347

  • Multiple clinical chemistry analyser IVD, laboratory

ADVIA® Chemistry CO2 Calibrator/Diluent - 00630414227887

Setpoint CO2 - ADVIA Chem. - CAL - 2x21mL
Siemens Healthcare Diagnostics Inc.
10326423
In Commercial Distribution

  • 00630414227887 ()
  • 00630414003603 ()
T23-1291-52

  • Carbon dioxide (CO2) IVD, calibrator

ADVIA Centaur AMH Kit - 00630414225692

AMH - Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998432
In Commercial Distribution

  • 00630414225692 ()
10998432

  • Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay
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