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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Atellica CH Dilution Ring Segment
Siemens Healthcare Diagnostics Inc.
11099327
In Commercial Distribution

  • 00630414596136 ()
11099327

  • Laboratory analyser cuvette IVD, reusable
Hemoglobin A1c_3 (A1c_3) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097500
Not in Commercial Distribution

  • 00630414596129 ()
11097500

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Ethanol_2 (ETOH) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097501
In Commercial Distribution

  • 00630414596112 ()
11097501

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Opiates (Op) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097502
In Commercial Distribution

  • 00630414596105 ()
11097502

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Cannabinoids (Thc) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097503
In Commercial Distribution

  • 00630414596099 ()
11097503

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Cocaine (Coc) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097504
In Commercial Distribution

  • 00630414596082 ()
11097504

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Benzodiazepine (Bnz) Atellica™ CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097505
In Commercial Distribution

  • 00630414596075 ()
11097505

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Amphetamine (Amp) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097506
In Commercial Distribution

  • 00630414596068 ()
11097506

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Barbiturates (Brb) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097507
In Commercial Distribution

  • 00630414596051 ()
11097507

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
Phencyclidine (Pcp) - Atellica CH - RGT - 1520T
Siemens Healthcare Diagnostics Inc.
11097509
In Commercial Distribution

  • 00630414596044 ()
11097509

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Phenytoin (Phny) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097510
In Commercial Distribution

  • 00630414596037 ()
11097510

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Atellica CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics Inc.
11097511
In Commercial Distribution

  • 00630414596020 ()
11097511

  • Vancomycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Valproic Acid (VPA) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097512
In Commercial Distribution

  • 00630414596013 ()
11097512

  • Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Theophylline (Theo) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097513
In Commercial Distribution

  • 00630414596006 ()
11097513

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Phenobarbital (Phnb) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097514
In Commercial Distribution

  • 00630414595993 ()
11097514

  • Phenobarbital IVD, kit, nephelometry/turbidimetry
Carbemazepine (Carb) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097515
In Commercial Distribution

  • 00630414595986 ()
11097515

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Gentamicin (Gent) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097516
In Commercial Distribution

  • 00630414595979 ()
11097516

  • Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Tobramycin (Tob) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097517
In Commercial Distribution

  • 00630414595962 ()
11097517

  • Tobramycin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Ecstasy (Xtc) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097518
In Commercial Distribution

  • 00630414595955 ()
11097518

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Propoxyphene (Ppx) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097519
In Commercial Distribution

  • 00630414595948 ()
11097519

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Wash 1 Atellica IM - CONS 1 x 3000mL
Siemens Healthcare Diagnostics Inc.
11098501
In Commercial Distribution

  • 00630414595931 ()
11098501

  • Buffered wash solution IVD
IM Cleaner Atellica IM - CONS 2x 1.5L
Siemens Healthcare Diagnostics Inc.
11098502
In Commercial Distribution

  • 00630414595924 ()
  • 00630414211480 ()
11098502

  • Wash/cleaning solution IVD, automated/semi-automated system
Methadone (Mdn) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097520
In Commercial Distribution

  • 00630414595917 ()
11097520

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Carbon dioxide (CO2_c) Atellica CH - RGT 7600T
Siemens Healthcare Diagnostics Inc.
11097521
In Commercial Distribution

  • 00630414595900 ()
  • 00630414006857 ()
11097521

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
Acetaminophen (Acet) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097522
In Commercial Distribution

  • 00630414595894 ()
11097522

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Salicylate (Sal) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097523
In Commercial Distribution

  • 00630414595887 ()
11097523

  • Salicylate IVD, kit, enzyme spectrophotometry
UrinaryTotal Protein (UPro) Atellica CH - RGT 1600T
Siemens Healthcare Diagnostics Inc.
11097524
Not in Commercial Distribution

  • 00630414595870 ()
  • 00630414006895 ()
11097524

  • Total protein IVD, kit, enzyme spectrophotometry
Digoxin (Dgn) Atellica CH - RGT 1600T
Siemens Healthcare Diagnostics Inc.
11097526
In Commercial Distribution

  • 00630414595863 ()
11097526

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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)
TD TRICYC ANTIDEPRESSANT ASSAY, TCA
Siemens Healthcare Diagnostics Inc.
11097528
In Commercial Distribution

  • 00630414595849 ()
11097528

  • Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)
Ammonia (Amm) Atellica CH – RGT 480T
Siemens Healthcare Diagnostics Inc.
11097529
In Commercial Distribution

  • 00630414595832 ()
  • 00630414006888 ()
11097529

  • Ammonia IVD, kit, spectrophotometry
Albumin BCP (AlbP) Atellica CH - RGT 6400T
Siemens Healthcare Diagnostics Inc.
11097530
In Commercial Distribution

  • 00630414595825 ()
  • 00630414006871 ()
11097530

  • Albumin IVD, kit, spectrophotometry
Total Bilirubin (Tbil_2) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097531
In Commercial Distribution

  • 00630414595818 ()
11097531

  • Total bilirubin IVD, kit, spectrophotometry
Direct Bilirubin (Dbil_2) Atellica CH - RGT 1792T
Siemens Healthcare Diagnostics Inc.
11097532
In Commercial Distribution

  • 00630414595801 ()
11097532

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Enzymatic Creatinine ( Ecrea_2) Atellica CH - RGT 1400T
Siemens Healthcare Diagnostics Inc.
11097533
In Commercial Distribution

  • 00630414595795 ()
11097533

  • Creatinine IVD, kit, spectrophotometry
EMPTY PACK Atellica CH - CONS
Siemens Healthcare Diagnostics Inc.
11097534
In Commercial Distribution

  • 00630414595788 ()
  • 00630414225777 ()
11097534

  • General laboratory assay tray
CH Diluent Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099300
In Commercial Distribution

  • 00630414595771 ()
  • 00630414006925 ()
11099300

  • Buffered sample diluent IVD
CH Conditioner Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099302
In Commercial Distribution

  • 00630414595764 ()
  • 00630414006970 ()
11099302

  • Wash/cleaning solution IVD, automated/semi-automated system
CH Cleaner Atellica CH - CONS 2 x 1.5L
Siemens Healthcare Diagnostics Inc.
11099303
In Commercial Distribution

  • 00630414595757 ()
  • 00630414006963 ()
11099303

  • Wash/cleaning solution IVD, automated/semi-automated system
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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