Medical device licence · 80313 · Class 4
IMMULITE 1000 SYSTEM (DPC-UK)
No longer licensed: cancelled
Licence status Cancelled; first licensed July 31, 2009; ended March 5, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 80313
- Licence holder
- Siemens Healthcare Diagnostics Products GmbhMarburg, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 31, 2009
- Ended
- March 5, 2019
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMULITE 1000 SYSTEM - ANTI-HBC ASSAY
- IMMULITE 1000 SYSTEM - ANTI-HBS ASSAY
- IMMULITE 1000 SYSTEM - HBSAG CONFIRMATORY KIT
- IMMULITE 1000 SYSTEM - HEPATITIS B SURFACE ANTIGEN (HBSAG) ASSAY
- IMMULITE 1000 SYSTEM - ID4 SAMPLE DILUENT
- IMMULITE 1000 SYSTEM - SYSTEM REAGENTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.