Medical device licence · 80315 · Class 4
IMMULITE 2000 SYSTEM (DPC-UK)
Yes: licensed in Canada
Licence status Issued (active); first licensed July 31, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80315
- Licence holder
- Siemens Healthcare Diagnostics Products GmbhMarburg, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 31, 2009
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMULITE 2000 SYSTEM - ANTI-HBC ASSAY
- IMMULITE 2000 SYSTEM - ANTI-HBC IGM ASSAY
- IMMULITE 2000 SYSTEM - ANTI-HBS ASSAY
- IMMULITE 2000 SYSTEM - HBSAG CONFIRMATORY KIT
- IMMULITE 2000 SYSTEM - HEPATITIS B SURFACE ANTIGEN (HBSAG) ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.