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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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Apolipoprotein A1 & B Calibrators Atellica CH - CAL 5 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099329
In Commercial Distribution

  • 00630414597317 ()
  • 00630414007120 ()
11099329

  • Multiple apolipoprotein IVD, calibrator
IMMULITE(R) 2000 TSI Assay
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10876421
In Commercial Distribution

  • 00630414597188 ()
L2KSI2(D)

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD
The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
Siemens Healthcare Diagnostics Products GmbH
10805311
In Commercial Distribution

  • 00630414596563 ()
10805311

  • Microscope slide stainer IVD
A-LYTE™ IMT (Na K Cl) Atellica CH - RGT
Siemens Healthcare Diagnostics Inc.
11099315
In Commercial Distribution

  • 00630414596518 ()
  • 00630414006833 ()
11099315

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
IMT Diluent Check Fluid Atellica CH - CONS 6 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099325
In Commercial Distribution

  • 00630414596150 ()
  • 00630414007069 ()
11099325

  • Multiple electrolyte IVD, reagent
Benzodiazepine (Bnz) Atellica™ CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097505
In Commercial Distribution

  • 00630414596075 ()
11097505

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Methadone (Mdn) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097520
In Commercial Distribution

  • 00630414595917 ()
11097520

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Atellica CH Methadone Metabolite (EDDP) (MetMtb)
Siemens Healthcare Diagnostics Inc.
11097527
Not in Commercial Distribution

  • 00630414595856 ()
11097527

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
IMT Standard A - Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099304
In Commercial Distribution

  • 00630414595740 ()
  • 00630414006949 ()
11099304

  • Multiple electrolyte IVD, calibrator
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