Medical device licence · 99044 · Class 2
ALINITY C SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 25, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99044
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 25, 2017
- Devices covered
- 43
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY C ALANINE AMINOTRANSFERASE REAGENT KIT
- ALINITY C ALBUMIN BCG REAGENT KIT
- ALINITY C ALBUMIN BCP REAGENT KIT
- ALINITY C ALKALINE PHOSPHATASE REAGENT KIT
- ALINITY C APOLIPOPROTEIN A1 REAGENT KIT
- ALINITY C APOLIPOPROTEIN B REAGENT KIT
- ALINITY C ASPARTATE AMINOTRANSFERASE REAGENT KIT
- ALINITY C BILIRUBIN CALIBRATOR KIT
- ALINITY C CALCIUM REAGENT KIT
- ALINITY C CARBON DIOXIDE CALIBRATOR KIT
- ALINITY C CARBON DIOXIDE REAGENT KIT
- ALINITY C CREATINE KINASE REAGENT KIT
- ALINITY C CREATININE REAGENT KIT
- ALINITY C DIRECT BILIRUBIN REAGENT KIT
- ALINITY C GAMMA-GLUTAMYL TRANSFERASE REAGENT KIT
- ALINITY C GLUCOSE REAGENT KIT
- ALINITY C HEMOGLOBIN A1C CALIBRATORS
- ALINITY C HEMOGLOBIN A1C CONTROLS
- ALINITY C HEMOGLOBIN A1C REAGENT KIT
- ALINITY C ICT SAMPLE DILUENT
- ALINITY C ICT SERUM CALIBRATOR KIT
- ALINITY C ICT URINE CALIBRATOR KIT
- ALINITY C IMMUNOGLOBULIN A REAGENT KIT
- ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
- ALINITY C LIPID MULTICONSTITUENT CALIBRATOR KIT
- ALINITY C MICROALBUMIN CALIBRATOR KIT
- ALINITY C MICROALBUMIN CONTROLS
- ALINITY C MICROALBUMIN REAGENT KIT
- ALINITY C MULTICONSTITUENT CALIBRATOR KIT
- ALINITY C PREALBUMIN CALIBRATOR KIT
- ALINITY C PREALBUMIN REAGENT KIT
- ALINITY C SPECIFIC PROTEINS MULTICONSTITUENT CALIBRATOR KIT
- ALINITY C TOTAL BILIRUBIN REAGENT KIT
- ALINITY C TOTAL PROTEIN REAGENT KIT
- ALINITY C TRANSFERRIN REAGENT KIT
- ALINITY C ULTRA HDL REAGENT KIT
- ALINITY C UREA NITROGEN REAGENT KIT
- ALINITY C URIC ACID REAGENT KIT
- ALINITY C URINE/CSF PROTEIN CALIBRATOR KIT
- ALINITY C URINE/CSF PROTEIN REAGENT KIT
- ALINITY C-SERIES ICT REFERENCE SOLUTION
- ALINITY SYSTEM SOFTWARE
- IRON CALIBRATOR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.