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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Albumin BCP (AlbP) Calibrator Atellica CH - CAL 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099310
In Commercial Distribution

  • 00630414597201 ()
  • 00630414007052 ()
11099310

  • Albumin IVD, calibrator
ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
APTIO INPUT/OUTPUT MODULE W/O SLOT
Siemens Healthcare Diagnostics Inc.
10713760
In Commercial Distribution

  • 00630414596754 ()
APT-201-01

  • Specimen processing instrument IVD
Check ReagentT Fluid (CHK) Atellica CH - CONS 4 X 47mL/4 X 47mL
Siemens Healthcare Diagnostics Inc.
11099311
In Commercial Distribution

  • 00630414596556 ()
  • 00630414211503 ()
11099311

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
Reagent Probe Cleaner 1 (RPC1) Atellica CH - CONS 4 X 44.6mL/4 X 44.6mL
Siemens Healthcare Diagnostics Inc.
11099312
In Commercial Distribution

  • 00630414596549 ()
  • 00630414211510 ()
11099312

  • Wash/cleaning solution IVD, automated/semi-automated system
Reagent Probe Cleaner 2 (RPC2) Atellica CH - CONS 4 X 44.6mL/4 X 44.6mL
Siemens Healthcare Diagnostics Inc.
11099313
In Commercial Distribution

  • 00630414596532 ()
  • 00630414211527 ()
11099313

  • Wash/cleaning solution IVD, automated/semi-automated system
Albumin BCG (Alb) Atellica CH - RGT 6800T
Siemens Healthcare Diagnostics Inc.
11097590
In Commercial Distribution

  • 00630414596501 ()
  • 00630414007182 ()
11097590

  • Albumin IVD, kit, nephelometry/turbidimetry
Triglycerides (Trig) Atellica CH - RGT 2000T
Siemens Healthcare Diagnostics Inc.
11097591
Not in Commercial Distribution

  • 00630414596495 ()
  • 00630414007199 ()
11097591

  • Triglyceride IVD, kit, spectrophotometry
Glucose Hexokinase ( GluH_3) Atellica CH - RGT 6240T
Siemens Healthcare Diagnostics Inc.
11097592
In Commercial Distribution

  • 00630414596488 ()
11097592

  • Glucose IVD, kit, spectrophotometry
Urea Nitrogen (UN_c) Atellica CH - RGT 6240T
Siemens Healthcare Diagnostics Inc.
11097593
In Commercial Distribution

  • 00630414596471 ()
11097593

  • Urea IVD, kit, enzyme spectrophotometry
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