Medical device licence · 67646 · Class 3
IMMULITE 2500 SYSTEM (DPC-LA)
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 3, 2005; ended October 31, 2011. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 67646
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 3, 2005
- Ended
- October 31, 2011
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMULITE 2500 SYSTEM
- IMMULITE 2500 SYSTEM - 3RD GEN PSA ASSAY
- IMMULITE 2500 SYSTEM - AFP ASSAY
- IMMULITE 2500 SYSTEM - CK-MB ASSAY
- IMMULITE 2500 SYSTEM - FREE PSA ASSAY
- IMMULITE 2500 SYSTEM - MYOGLOBIN ASSAY
- IMMULITE 2500 SYSTEM - NT-PROBNP ASSAY
- IMMULITE 2500 SYSTEM - PSA ASSAY
- IMMULITE 2500 SYSTEM - RUBELLA IGG ASSAY
- IMMULITE 2500 SYSTEM - RUBELLA IGM ASSAY
- IMMULITE 2500 SYSTEM - TOXOPLASMA IGG ASSAY
- IMMULITE 2500 SYSTEM - TOXOPLASMA IGM ASSAY
- IMMULITE 2500 SYSTEM - TROPONIN I ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.