Medical device licence · 3890 · Class 3
REFLOTRON SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed June 2, 1999; ended May 15, 2014. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 3890
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 2, 1999
- Ended
- May 15, 2014
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REFLOTRON PRECINORM HDL (CONTROL FOR REFLOTRON HDL CHOLESTOROL)
- REFLOTRON SYSTEM - ALKALINE PHOSPHATASE
- REFLOTRON SYSTEM - AMYLASE
- REFLOTRON SYSTEM - BILIRUBIN
- REFLOTRON SYSTEM - CHOLESTEROL
- REFLOTRON SYSTEM - CK
- REFLOTRON SYSTEM - CREATININE
- REFLOTRON SYSTEM - GGT
- REFLOTRON SYSTEM - GLUCOSE
- REFLOTRON SYSTEM - GOT (AST)2
- REFLOTRON SYSTEM - GPT (ALT)1
- REFLOTRON SYSTEM - HDL CHOLESTEROL
- REFLOTRON SYSTEM - HEMOGLOBIN
- REFLOTRON SYSTEM - POTASSIUM
- REFLOTRON SYSTEM - PRECINORM HB (CONTROL FOR REFLOTRON HEMOGLOBIN)
- REFLOTRON SYSTEM - PRECINORM U (UNIVERSAL CONTROL FOR REFLOTRON)
- REFLOTRON SYSTEM - REFURBISHED ANALYZER CLASS 3
- REFLOTRON SYSTEM - TRIGLYCERIDE
- REFLOTRON SYSTEM - UREA
- REFLOTRON SYSTEM -US CALIBRATORS LIGHT, BLACK, WHITE
- REFLOTRON URIC ACID
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.