Medical device licence · 79670 · Class 3
DIMENSION EXL SYSTEM (CLASS 3)
Yes: licensed in Canada
Licence status Issued (active); first licensed May 4, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79670
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 4, 2009
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CTNI SAMPLE DILUENT
- DIMENSION CLINICAL CHEMISTRY SYSTEM TAC CAL
- DIMENSION CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TAC) FLEX REAGENT CARTRIDGE
- DIMENSION EXL SYS - N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) ASSAY
- DIMENSION EXL SYSTEM - (TROPONIN) TNI ASSAY
- DIMENSION EXL SYSTEM - CARDIAC TROPONIN-I (CTNI) ASSAY
- DIMENSION EXL SYSTEM - CREATINE KINASE MB (MBI) ASSAY
- DIMENSION EXL SYSTEM - CREATINE KINASE MB ISOENZYME (CKMB) ASSAY
- DIMENSION EXL SYSTEM - CYCLOSPORINE (CSA) ASSAY
- DIMENSION EXL SYSTEM - DIMENSION EXL 200 ANALYZER
- DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER
- DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LM
- DIMENSION EXL SYSTEM - FREE PSA (FPSA) ASSAY
- DIMENSION EXL SYSTEM - LOCI HIGH SENSITIVITY TROPONIN I (TNIH)
- DIMENSION EXL SYSTEM - LOCI MODULE UPGRADE KIT
- DIMENSION EXL SYSTEM - MASS CREATINE KINASE MB ISOENZYME (MMB) ASSAY
- DIMENSION EXL SYSTEM - MYOGLOBIN (MYO) ASSAY
- DIMENSION EXL SYSTEM - NTP ASSAY (N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE)
- DIMENSION EXL SYSTEM - SIROLIMUS (SIRO) ASSAY
- DIMENSION EXL SYSTEM - TACROLIMUS (TACR) ASSAY
- DIMENSION EXL SYSTEM - TOTAL PSA (TPSA) ASSAY
- DIMENSION EXL SYSTEM -LOCI HIGH SENSITIVITY TROPONIN I CALIBRATOR (LOCI TNIH CAL)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.