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 CH Bilirubin Calibrator (BILI CAL)
Siemens Healthcare Diagnostics Inc.
11537243
In Commercial Distribution

  • 00630414313450 ()
  • 00630414615097 ()
11537243

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Atellica CH Prealbumin (PALB)
Siemens Healthcare Diagnostics Inc.
11537217
In Commercial Distribution

  • 00630414313412 ()
  • 00630414614939 ()
11537217

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537220
In Commercial Distribution

  • 00630414313436 ()
  • 00630414614922 ()
11537220

  • Total bilirubin IVD, kit, spectrophotometry
Atellica CH Diazo Direct Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537219
In Commercial Distribution

  • 00630414313429 ()
  • 00630414614755 ()
11537219

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
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
Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette
Siemens Healthcare Diagnostics Inc.
10634643
In Commercial Distribution

  • 00630414602653 ()
10634643

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
ADVIA® 360/560 Dil 20L
Siemens Healthcare Diagnostics Inc.
11170845
In Commercial Distribution

  • 00630414601274 ()
D1512

  • Buffered sample diluent IVD
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
Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995520
In Commercial Distribution

  • 00630414598475 ()
  • 00630414190914 ()
10995520

  • Complexed prostate specific antigen (cPSA) IVD, calibrator
Uric Acid (UA) Atellica CH - RGT 4800T
Siemens Healthcare Diagnostics Inc.
11097608
In Commercial Distribution

  • 00630414596334 ()
11097608

  • Uric acid IVD, kit, spectrophotometry
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