Medical device licence · 99367 · Class 2
ARCHITECT C SYSTEM ASSAYS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99367
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 29, 2017
- Devices covered
- 35
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALANINE AMINOTRANSFERASE (ALT)
- ALBUMIN BCG
- ALKALINE PHOSPHATASE ASSAY
- APOLIPOPROTEIN A1
- APOLIPOPROTEIN B
- ARCHITECT C 16000 - CALCIUM ASSAY
- ARCHITECT HEMOGLOBIN A1C CALIBRATORS
- ARCHITECT HEMOGLOBIN A1C CONTROLS
- ARCHITECT HEMOGLOBIN A1C REAGENT
- ARCHITECT SYSTEM - CREATININE ASSAY
- ARCHITECT SYSTEM - CREATININE KINASE ASSAY
- ARCHITECT SYSTEM - GGT ASSAY
- ARCHITECT SYSTEM - LACTATE DEHYDROGENASE ASSAY
- ARCHITECT SYSTEM - MAGNESIUM ASSAY
- ARCHITECT SYSTEM - PREALBUMIN ASSAY
- ARCHITECT SYSTEM - ULTRA HDL ASSAY
- ARCHITECT SYSTEM - UREA NITROGEN ASSAY
- ARCHITECT SYSTEM - URINE/CSF PROTEIN ASSAY
- ASPARTATE AMINOTRANSFERASE (AST) REAGENT KIT
- BILIRUBIN CALIBRATOR
- CARBON DIOXIDE
- CARBON DIOXIDE CALIBRATOR
- DIRECT BILIRUBIN
- GLUCOSE
- ICT REFERENCE SOLUTIONS
- ICT SERUM CALIBRATOR
- ICT URINE CALIBRATOR
- IMMUNOGLOBULIN A
- LIPID MULTICONSTITUENT CALIBRATOR
- MULTICONSTITUENT CALIBRATOR
- SPECIFIC PROTEINS MULTICONSTITUENT CALIBRATOR
- TOTAL BILIRUBIN
- TOTAL PROTEIN REAGENT KIT
- TRANSFERRIN
- URIC ACID
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.