Medical device licence · 5039 · Class 2
SYCHRON AS CLINICAL SYSTEMS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 9, 1999; ended October 31, 1999. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 5039
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 9, 1999
- Ended
- October 31, 1999
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASTRA SYSTEM BUN REAGENT KIT
- ASTRA SYSTEM CHOLESTEROL REAGENT KIT
- ASTRA SYSTEM DIRECT BILIRUBIN CUP REAGENT
- ASTRA SYSTEMS ALBUMIN REAGENT KIT
- ASTRA SYSTEMS ALT REAGENT KIT
- ASTRA SYSTEMS AMYLASE REAGENT KIT
- ASTRA SYSTEMS AP REAGENT KIT
- ASTRA SYSTEMS AST REAGENT KIT
- ASTRA SYSTEMS CALCIUM REAGENT KIT
- ASTRA SYSTEMS CK REAGENT KIT
- ASTRA SYSTEMS CO2 REAGENT KIT
- ASTRA SYSTEMS CREATININE REAGENT KIT
- ASTRA SYSTEMS GAMMA-GT KIT
- ASTRA SYSTEMS GLUCOSE REAGENT KIT
- ASTRA SYSTEMS INORGANIC PHOSPHORUS REAGENT KIT
- ASTRA SYSTEMS LD-L REAGENT KIT
- ASTRA SYSTEMS LD-P REAGENT KIT
- ASTRA SYSTEMS SODIUM/POTASSIUM REAGENT KIT
- ASTRA SYSTEMS TOTAL BILIRUBIN KIT
- ASTRA SYSTEMS TOTAL PROTEIN REAGENT KIT
- ASTRA SYSTEMS TRIGLYCERIDES CALIBRATOR E
- ASTRA SYSTEMS URIC ACID KIT
- SYNCHRON AS CLINICAL ANALYZER - CLASS 2
- SYSTEMS CHLORIDE REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.