Medical device licence · 1076 · Class 3
IMMULITE SYSTEM (DPC-LA)
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed February 5, 1999; ended October 31, 2011. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 1076
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 5, 1999
- Ended
- October 31, 2011
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMULITE SYSTEM - ALPHA FETOPROTIEN (AFP) ASSAY
- IMMULITE SYSTEM - CARDIAC CONTROL MODULE
- IMMULITE SYSTEM - CEA ASSAY
- IMMULITE SYSTEM - CHEMILUMINESCENT IMMUNOASSAY ANALYZER CLASS 3
- IMMULITE SYSTEM - CK-MB ASSAY
- IMMULITE SYSTEM - CMV IGG ASSAY
- IMMULITE SYSTEM - FREE PSA ASSAY
- IMMULITE SYSTEM - HERPES I & II IGG ASSAY
- IMMULITE SYSTEM - HERPES I & II IGM ASSAY
- IMMULITE SYSTEM - MYOGLOBIN ASSAY
- IMMULITE SYSTEM - PSA ASSAY
- IMMULITE SYSTEM - RUBELLA IGG ASSAY
- IMMULITE SYSTEM - RUBELLA IGG QUANTITATIVE ASSAY
- IMMULITE SYSTEM - RUBELLA QUALITATIVE IGM ASSAY
- IMMULITE SYSTEM - THIRD GENERATION PSA ASSAY
- IMMULITE SYSTEM - TOXOPLASMA IGM ASSAY
- IMMULITE SYSTEM - TOXOPLASMA QUANTITATIVE IGG ASSAY
- IMMULITE SYSTEM - TROPONIN I ASSAY
- IMMULITE SYSTEM - TURBO CK-MB ASSAY
- IMMULITE SYSTEM - TURBO MYOGLOBIN ASSAY
- IMMULITE SYSTEM - TURBO TROPONIN I ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.