Medical device licence · 1199 · Class 2
ARCHITECT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 5, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 1199
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 5, 1999
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT I - PHENYTOIN ASSAY
- ARCHITECT I SYSTEM - CONTROL CENTRE (SCC) I 2000
- ARCHITECT I SYSTEM - DIGOXIN ASSAY
- ARCHITECT I SYSTEM - I1000SR PROCESSING MODULE CLASS 2
- ARCHITECT I SYSTEM - I2000SR PROCESSING MODULE (REFUR)
- ARCHITECT I SYSTEM - SOFTWARE
- ARCHITECT LIPID MULTICONSTITUENT CALIBRATOR
- ARCHITECT SYSTEM - ALKALINE PHOSPHATASE ASSAY
- ARCHITECT SYSTEM - ANALYZER - CLASS 2
- ARCHITECT SYSTEM - BILIRUBIN CALIBRATOR
- ARCHITECT SYSTEM - CALCIUM ASSAY
- ARCHITECT SYSTEM - CARBON DIOXIDE ASSAY
- ARCHITECT SYSTEM - CREATININE ASSAY
- ARCHITECT SYSTEM - HEMOGLOBIN A1C CALIBRATORS
- ARCHITECT SYSTEM - HEMOGLOBIN A1C CONTROLS
- ARCHITECT SYSTEM - HEMOGLOBIN A1C REAGENT KIT
- ARCHITECT SYSTEM - IPHENOBARBITAL ASSAY
- ARCHITECT SYSTEM - IRON ASSAY
- ARCHITECT SYSTEM - LIPASE ASSAY
- ARCHITECT SYSTEM - MULTICONSTITUENT CALIBRATOR
- ARCHITECT SYSTEM - T-UPTAKE ASSAY
- ARCHITECT SYSTEM - URINE/CSF PROTEIN ASSAY
- ARCHITECT SYSTEM- RHEUMATOID FACTOR ASSAY (CALIBRATOR)
- ARCHITECT SYSTEM- TOTAL BILIRUBIN ASSAY (CALIBRATOR)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.