Medical device licence · 79747 · Class 4
ADVIA CENTAUR CP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 20, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79747
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- May 20, 2009
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADVIA CENTAUR CP SYS-HIV AG/AB COMBO (CHIV) ASSAY(DONOR SCREEN TRANSPLANT)
- ADVIA CENTAUR CP SYSTEM - ANTI-HBE (AHBE) ASSAY
- ADVIA CENTAUR CP SYSTEM - ANTI-HBS (AHBS) ASSAY
- ADVIA CENTAUR CP SYSTEM - ANTI-HBS2 (AHBS2) ASSAY
- ADVIA CENTAUR CP SYSTEM - HAPATITIS B E ANTIGEN (HBEAG) ASSAY
- ADVIA CENTAUR CP SYSTEM - HBC IGM (AHBCM) ASSAY
- ADVIA CENTAUR CP SYSTEM - HBSAG CONFIRMATORY (CONF) ASSAY
- ADVIA CENTAUR CP SYSTEM - HBSAGII (HBSII) ASSAY (DONOR SCREEN TRANSPLANT)
- ADVIA CENTAUR CP SYSTEM - HCV ASSAY (DONOR SCREENING FOR TRANSPLANTATION)
- ADVIA CENTAUR CP SYSTEM - INSTRUMENT CLASS IV
- ADVIA CENTAUR CP SYSTEM - MULTI-DILUENT
- ADVIA CENTAUR CP SYSTEM - SYPHILIS (SYPH) ASSAY (DONOR SCREENING FOR TRANSPLANTATION)
- ADVIA CENTAUR CP SYSTEM - SYPHILIS (SYPH) QC
- ADVIA CENTAUR CP SYSTEM - SYSTEM REAGENTS
- ADVIA CENTAUR CP SYSTEM-H0IV1/O/2 ENHANCED(EHIV) ASSAY(DONOR SCREEN TRANSP)
- ADVIA CENTAUR CP SYSTEM-HBC TOTAL (HBCT) ASSAY(DONOR SCREENING FOR TRANSPL)
- ADVIA CENTAUR CP SYSTEM-HBSAG(HBS) ASSAY (FOR DONOR SCREENING FOR TRANSPLA)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.