Medical device licence · 7757 · Class 3
DIMENSION CHEMISTRY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 19, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 7757
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 19, 1999
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIMENSION CHEMISTRY SYS - (FPSA)FREE PROSTATE SPECIFIC ANTIGEN FLEX REAGENT
- DIMENSION CHEMISTRY SYS- (TPSA)TOTAL PROSTATE SPECIFIC ANTIGEN FLEX REAGENT
- DIMENSION CHEMISTRY SYSTEM - CREATINE KINASE MB (MBI) ASSAY
- DIMENSION CHEMISTRY SYSTEM - CSAE FLEX REAGENT CYCLOSPORINE A
- DIMENSION CHEMISTRY SYSTEM - CYCLOSPORINE FLEX REAGENT CARTRIDGE
- DIMENSION CHEMISTRY SYSTEM - DIMENSION RXL MAX W/HM ANALYZER
- DIMENSION CHEMISTRY SYSTEM - MASS CKMB
- DIMENSION CHEMISTRY SYSTEM - MYOGLOBIN (MYO) FLEX REAGENT
- DIMENSION CHEMISTRY SYSTEM - PBNP CALIBRATOR
- DIMENSION CHEMISTRY SYSTEM - PBNP FLEX REAGENT CARTRIDGE
- DIMENSION CHEMISTRY SYSTEM - PBNP NT-PROBNP FLEX ASSAY(NATRIURETIC PEPTIDE)
- DIMENSION CHEMISTRY SYSTEM - REAGENT MANAGEMENT SYSTEM
- DIMENSION CHEMISTRY SYSTEM - RXL ANALYZER - CLASS 3
- DIMENSION CHEMISTRY SYSTEM - RXL MAX ANALYZER CLASS 3
- DIMENSION CHEMISTRY SYSTEM - SIROLIMUS (SIRO) ASSAY
- DIMENSION CHEMISTRY SYSTEM - TACR FLEX REAGENT
- DIMENSION CHEMISTRY SYSTEM - TOTAL/FREE PSA CALIBRATOR
- DIMENSION CHEMISTRY SYSTEM - TROPONIN I
- DIMENSION CLINICAL CHEMISTRY SYSTEM TAC CAL
- DIMENSION CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TAC) FLEX REAGENT CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.