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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Oxycodone (OXYC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701333
In Commercial Distribution

  • 00630414322025 ()
  • 00630414654225 ()
11701333

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Opiates (OpC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701332
In Commercial Distribution

  • 00630414322018 ()
  • 00630414654218 ()
11701332

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Ecstasy (XtcC) Atellica CH - RGT 100T
Siemens Healthcare Diagnostics Inc.
11701329
In Commercial Distribution

  • 00630414321974 ()
  • 00630414654201 ()
11701329

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Cocaine (CocC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701328
In Commercial Distribution

  • 00630414321967 ()
  • 00630414654195 ()
11701328

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Benzodiazepine (BnzC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701326
In Commercial Distribution

  • 00630414321943 ()
  • 00630414654188 ()
11701326

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Amphetamine (AmpC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701324
In Commercial Distribution

  • 00630414321929 ()
  • 00630414654171 ()
11701324

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Acetaminophen (AcetC) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11701323
In Commercial Distribution

  • 00630414321912 ()
  • 00630414654164 ()
11701323

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Ethanol (EtohC) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11701330
In Commercial Distribution

  • 00630414321981 ()
  • 00630414654089 ()
11701330

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Cannabinoids (ThcC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701327
In Commercial Distribution

  • 00630414321950 ()
  • 00630414654072 ()
11701327

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Barbiturates (BrbC) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11701325
In Commercial Distribution

  • 00630414321936 ()
  • 00630414654065 ()
11701325

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Refurbished Atellica CH930 instrument
Siemens Healthcare Diagnostics Inc.
11768553
In Commercial Distribution

  • 00630414651637 ()
11067000

  • Multiple clinical chemistry analyser IVD, laboratory
Atellica IM 1300 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764765
In Commercial Distribution

  • 00630414650579 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
Protein 1 Calibrator
Siemens Healthcare Diagnostics Inc.
11537520
In Commercial Distribution

  • 00630414313467 ()
  • 00630414636672 ()
11537520

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Atellica IM DHEASII MCM SET
Siemens Healthcare Diagnostics Inc.
11209195
In Commercial Distribution

  • 00630414632940 ()
11209195

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
Atellica IM DHEASII 100T KIT
Siemens Healthcare Diagnostics Inc.
11209193
In Commercial Distribution

  • 00630414632926 ()
11209193

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Test Strips for the Determination of Albumin and Creatinine in Urine
Siemens Healthcare Diagnostics Inc.
11643376
In Commercial Distribution

  • 00630414317434 ()
  • 00630414631707 ()


  • Urine protein IVD, kit, rapid colorimetric, clinical
Test strips for urinary tract infection
Siemens Healthcare Diagnostics Inc.
11643375
In Commercial Distribution

  • 00630414317427 ()
  • 00630414631677 ()
11643375

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Gamma-Glutamyl Transferase (GGT_2) Reagents
Siemens Healthcare Diagnostics Inc.
11537248
In Commercial Distribution

  • 00630414313382 ()
  • 00630414628707 ()
11537248

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
PBNPII - ATELLICA IM - MCM Set
Siemens Healthcare Diagnostics Inc.
11204754
In Commercial Distribution

  • 00630414626970 ()
11204754

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
PBNPII - ADVIA Centaur - MCM Set
Siemens Healthcare Diagnostics Inc.
11204753
In Commercial Distribution

  • 00630414626963 ()
11204753

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
TSH3-ULII ADVIA Centaur - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208875
In Commercial Distribution

  • 00630414624709 ()
11208875

  • Thyroid stimulating hormone (TSH) IVD, control
TSH3-ULII Atellica IM - RGT (REF) 2750T
Siemens Healthcare Diagnostics Inc.
11208704
In Commercial Distribution

  • 00630414624693 ()
11208704

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208876
In Commercial Distribution

  • 00630414624532 ()
11208876

  • Thyroid stimulating hormone (TSH) IVD, control
TSH3-ULII Atellica IM – RGT 550T
Siemens Healthcare Diagnostics Inc.
11208707
In Commercial Distribution

  • 00630414624525 ()
11208707

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII Atellica IM - RGT 110T
Siemens Healthcare Diagnostics Inc.
11208706
In Commercial Distribution

  • 00630414624518 ()
11208706

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
Siemens Healthcare Diagnostics Inc.
11208703
In Commercial Distribution

  • 00630414624501 ()
11208703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-ULII ADVIA Centaur - RGT 500T
Siemens Healthcare Diagnostics Inc.
11208702
In Commercial Distribution

  • 00630414624488 ()
11208702

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
ATELLICA IM ELF KIT
Siemens Healthcare Diagnostics Inc.
11208118
In Commercial Distribution

  • 00630414618463 ()
11208118

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
ADVIA CENTAUR ELF MCM SET
Siemens Healthcare Diagnostics Inc.
11208709
In Commercial Distribution

  • 00630414618456 ()
11208709

  • Multiple liver fibrosis marker IVD, control
ADVIA CENTAUR ELF KIT
Siemens Healthcare Diagnostics Inc.
11207300
In Commercial Distribution

  • 00630414618128 ()
11207300

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay
ATELLICA IM ELF MCM SET
Siemens Healthcare Diagnostics Inc.
11208708
In Commercial Distribution

  • 00630414618111 ()
11208708

  • Multiple liver fibrosis marker IVD, control
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 Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537220
In Commercial Distribution

  • 00630414313436 ()
  • 00630414614922 ()
11537220

  • Total bilirubin IVD, kit, spectrophotometry
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 Microalbumin (UAlb) Calibrator
Siemens Healthcare Diagnostics Inc.
11537247
In Commercial Distribution

  • 00630414320304 ()
  • 00630414611204 ()
11537247

  • Albumin 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
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