Medical device licence · 99022 · Class 2
ALINITY I SYSTEM ASSAYS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 21, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99022
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 21, 2017
- Devices covered
- 44
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY I 25-OH VITAMIN D
- ALINITY I B12 CALIBRATORS
- ALINITY I B12 CONTROLS
- ALINITY I B12 REAGENT KIT
- ALINITY I ESTRADIOL CALIBRATORS
- ALINITY I ESTRADIOL CONTROLS
- ALINITY I ESTRADIOL MANUAL DILUENT KIT
- ALINITY I ESTRADIOL REAGENT KIT
- ALINITY I FERRITIN CALIBRATORS
- ALINITY I FERRITIN CONTROLS
- ALINITY I FERRITIN REAGENT KIT
- ALINITY I FOLATE CALIBRATORS
- ALINITY I FOLATE CONTROLS
- ALINITY I FOLATE LYSIS REAGENT
- ALINITY I FOLATE MANUAL DILUENT
- ALINITY I FOLATE RBC LYSIS DILUENT
- ALINITY I FOLATE REAGENT KIT
- ALINITY I FREE T3 CALIBRATORS
- ALINITY I FREE T3 CONTROLS
- ALINITY I FREE T3 REAGENT KIT
- ALINITY I FREE T4 CALIBRATORS
- ALINITY I FREE T4 CONTROLS
- ALINITY I FREE T4 REAGENT KIT
- ALINITY I FSH CALIBRATORS
- ALINITY I FSH CONTROLS
- ALINITY I FSH REAGENT KIT
- ALINITY I LH CALIBRATORS
- ALINITY I LH REAGENT KIT
- ALINITY I PROGESTERONE CALIBRATORS
- ALINITY I PROGESTERONE CONTROLS
- ALINITY I PROGESTERONE MANUAL DILUENT
- ALINITY I PROGESTERONE REAGENT KIT
- ALINITY I PROLACTIN
- ALINITY I TOTAL B-HCG
- ALINITY I TOTAL T3 CALIBRATORS
- ALINITY I TOTAL T3 MANUAL DILUENT
- ALINITY I TOTAL T3 REAGENT KIT
- ALINITY I TOTAL T4 CALIBRATORS
- ALINITY I TOTAL T4 CONTROLS
- ALINITY I TOTAL T4 REAGENT KIT
- ALINITY I TSH
- ALINITY I URINE NGAL CALIBRATORS
- ALINITY I URINE NGAL CONTROLS
- ALINITY I URINE NGAL REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.