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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Atellica IM Base solution
Siemens Healthcare Diagnostics Inc.
11417930
In Commercial Distribution

  • 00630414613437 ()
  • 00630414317014 ()
11417930

  • Chemiluminescent immunoassay signal generation kit IVD
Atellica IM Acid
Siemens Healthcare Diagnostics Inc.
11417929
In Commercial Distribution

  • 00630414613239 ()
  • 00630414317007 ()
11417929

  • Chemiluminescent immunoassay signal generation kit IVD
A-LYTE IMT Cleaner
Siemens Healthcare Diagnostics Inc.
11556782
In Commercial Distribution

  • 00630414302751 ()
  • 00630414611617 ()
11556782

  • Wash/cleaning solution IVD, automated/semi-automated system
Atellica CH C-Reactive Protein Calibrator (RCRP CAL)
Siemens Healthcare Diagnostics Inc.
11537245
In Commercial Distribution

  • 00630414305141 ()
  • 00630414611297 ()
11537245

  • C-reactive protein (CRP) IVD, calibrator
Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
Siemens Healthcare Diagnostics Inc.
11537224
In Commercial Distribution

  • 00630414305028 ()
  • 00630414611112 ()
11537224

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Atellica CH Total Protein (TP_2)
Siemens Healthcare Diagnostics Inc.
11537228
In Commercial Distribution

  • 00630414306025 ()
  • 00630414611082 ()
11537228

  • Total protein IVD, kit, spectrophotometry
Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
DV/DM COV2T/CV2T CAL
Siemens Healthcare Diagnostics Inc.
11417413
Not in Commercial Distribution

  • 00630414297606 ()
  • 00630414605494 ()
KC813

  • SARS-CoV-2 total antibody IVD, calibrator
DV/DM COV2T/CV2T POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417415
Not in Commercial Distribution

  • 00630414297620 ()
  • 00630414605425 ()
KC815

  • SARS-CoV-2 total antibody IVD, control
Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
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