Medical device licence · 33405 · Class 3
DIMENSION XPAND SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 31, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 33405
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 31, 2001
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIMENSION CLINICAL CHEMISTRY SYSTEM TAC CAL
- DIMENSION CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TAC) FLEX REAGENT CARTRIDGE
- DIMENSION XPAND SYSTEM - CREATINE KINASE MB (MBI) ASSAY
- DIMENSION XPAND SYSTEM - CREATINE KINASE MB ISOENZYME (CKMB) ASSAY
- DIMENSION XPAND SYSTEM - CSAE FLEX REAGENT CYCLOSPORINE A
- DIMENSION XPAND SYSTEM - CYCLOSPORINE (CSA) ASSAY
- DIMENSION XPAND SYSTEM - DIMENSION XPAND HM ANALYZER - CLASS 3
- DIMENSION XPAND SYSTEM - FREE PROSTATE SPECIFIC ANTIGEN (FPSA) ASSAY
- DIMENSION XPAND SYSTEM - LMMB MASS CREATINE KINASE MB ISOENZYME FLEX ASSAY
- DIMENSION XPAND SYSTEM - LTNI CARDIAC TROPONIN I FLEX ASSAY
- DIMENSION XPAND SYSTEM - MYOGLOBIN (MYO) ASSAY
- DIMENSION XPAND SYSTEM - PBNP FLEX REAGENT CARTRIDGE
- DIMENSION XPAND SYSTEM - SIROLIMUS (SIRO) ASSAY
- DIMENSION XPAND SYSTEM - TACR FLEX REAGENT
- DIMENSION XPAND SYSTEM - TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY
- DIMENSION XPAND SYSTEM - XPAND PLUS BASIC ANALYZER
- DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.