ApprovalTrail

Medical device licence · 62866 · Class 4

ADVIA CENTAUR SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 31, 2003. It is in Health Canada’s list of active licences.
Licence number
62866
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
July 31, 2003
Devices covered
21

Devices on this licence

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

  • ADVIA CENTAUR ANTI-HBE2 (AHBE2)
  • ADVIA CENTAUR ANTI-HBE2 QUALITY CONTROL (AHBE2 QC)
  • ADVIA CENTAUR SYS-HIV AG/AB COMBO (CHIV) ASSAY (DONOR SCREEN TRANSPLANT)
  • ADVIA CENTAUR SYSTEM - ANTI-HBE ASSAY
  • ADVIA CENTAUR SYSTEM - ANTI-HBS (AHBS) ASSAY
  • ADVIA CENTAUR SYSTEM - ANTI-HBS2 (AHBS2) ASSAY
  • ADVIA CENTAUR SYSTEM - HBC IGM (AHBCM) ASSAY
  • ADVIA CENTAUR SYSTEM - HBEAG ASSAY
  • ADVIA CENTAUR SYSTEM - HBSAG CONFIRMATORY (CONF) ASSAY
  • ADVIA CENTAUR SYSTEM - HBSAGII (HBSII) ASSAY (DONOR SCREEN TRANSPLANT)
  • ADVIA CENTAUR SYSTEM - HCV ASSAY(FOR DONOR SCREENING FOR TRANSPLANTATION)
  • ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS IV
  • ADVIA CENTAUR SYSTEM - MULTI-DILUENTS
  • ADVIA CENTAUR SYSTEM - SYPHILIS (SYPH) ASSAY (DONOR SCREENING FOR TRANSPLANTATION)
  • ADVIA CENTAUR SYSTEM - SYPHILIS (SYPH) QC
  • ADVIA CENTAUR SYSTEM - SYSTEM REAGENTS
  • ADVIA CENTAUR SYSTEM-HBC TOTAL (HBCT) ASSAY(DONOR SCREENING FOR TRANSPLANT)
  • ADVIA CENTAUR SYSTEM-HBSAG(HBS) ASSAY(DONOR SCREENING FOR TRANSPLANTATION)
  • ADVIA CENTAUR SYSTEM-HIV1/O/2 ENHANCED (EHIV) ASSAY(DONOR SCREEN TRANSPLAN)
  • ADVIA CENTAUR XP INSTRUMENT
  • ADVIA CENTAUR XPT INSTRUMENT

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