ApprovalTrail

Medical device licence · 11279 · Class 2

X SYSTEMS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 2, 1999; ended October 25, 2017. It is in Health Canada’s archive of licences no longer in force.
Licence number
11279
Licence holder
Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
September 2, 1999
Ended
October 25, 2017
Devices covered
44

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • X SYSTEMS PHENOBARBITAL ASSAY
  • X SYSTEMS ACETAMINOPHEN ASSAY
  • X SYSTEMS AMIKACIN ASSAY
  • X SYSTEMS ANPHETAMINE/ METHAMPHETAMINE ASSAY
  • X SYSTEMS CABAMAZEPINE ASSAY
  • X SYSTEMS CANNABINOIDS ASSAY
  • X SYSTEMS COCAINE METABOLITE ASSAY
  • X SYSTEMS CORTISOL ASSAY
  • X SYSTEMS CRP ASSAY
  • X SYSTEMS DIGOXIN ASSAY
  • X SYSTEMS DISOPYRAMIDE ASSAY
  • X SYSTEMS ETHANOL ASSAY
  • X SYSTEMS ETHOSUXIMIDE ASSAY
  • X SYSTEMS FLECAINIDE ASSAY
  • X SYSTEMS FLX AUTOMATED ANALYZER - CLASS 2
  • X SYSTEMS FREE PHENYTOIN ASSAY
  • X SYSTEMS GENTAMICIN ASSAY
  • X SYSTEMS LACTIC ACID ASSAY
  • X SYSTEMS LIDOCAINE ASSAY
  • X SYSTEMS MEGX ASSAY
  • X SYSTEMS METHODONE ASSAY
  • X SYSTEMS METHOTREXATE II ASSAY
  • X SYSTEMS N-ACETYLPROCAINAMIDE ASSAY
  • X SYSTEMS NETILMYCIN ASSAY
  • X SYSTEMS OPIATES ASSAY
  • X SYSTEMS PHENYCLIDINE II ASSAY
  • X SYSTEMS PHENYTOIN II ASSAY
  • X SYSTEMS PRIMIDONE ASSAY
  • X SYSTEMS PROCAINAMIDE ASSAY
  • X SYSTEMS PROPOXYPHENE ASSAY
  • X SYSTEMS QUINIDINE ASSAY
  • X SYSTEMS SALICYLATE ASSAY
  • X SYSTEMS SERUM BARBITUATES ASSAY
  • X SYSTEMS SERUM BENZODIAZEPINE ASSAY
  • X SYSTEMS T-UPTAKE ASSAY
  • X SYSTEMS T4 ASSAY
  • X SYSTEMS TDX ANALYZER - CLASS 2
  • X SYSTEMS THEOPHYLLINE ASSAY
  • X SYSTEMS TOBRAMYCIN ASSAY
  • X SYSTEMS TOTAL ESTRIOL ASSAY
  • X SYSTEMS TRICYCLIC ANTIDEPRESSANTS ASSAY
  • X SYSTEMS URINE BENZODIAZEPINES ASSAY
  • X SYSTEMS VALPROIC ACID ASSAY
  • X SYSTEMS VANCOMYCIN ASSAY

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.