Medical device licence · 33391 · Class 3
ADVIA INTEGRATED MODULAR SYSTEM (IMS)
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 1, 2001; ended November 1, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 33391
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 1, 2001
- Ended
- November 1, 2010
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADVIA IMS - AFP (ALPHA FETAL PROTEIN) ASSAY
- ADVIA IMS - ANALYZER CLASS 3
- ADVIA IMS - BNP ASSAY
- ADVIA IMS - CA 125 ASSAY
- ADVIA IMS - CA 15-3 ASSAY
- ADVIA IMS - CA 19-9 ASSAY
- ADVIA IMS - CEA ASSAY
- ADVIA IMS - CK-MB ASSAY
- ADVIA IMS - CPSA ASSAY
- ADVIA IMS - MYOGLOBIN ASSAY
- ADVIA IMS - PSA ASSAY
- ADVIA IMS - SYSTEM CA 72-4 ASSAY
- ADVIA IMS - TNI-UL REAGENT PACK
- ADVIA IMS - TROPONIN I ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.