Medical device licence · 93561 · Class 2
AQUIOS CL FLOW CYTOMETER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93561
- Licence holder
- Beckman Coulter Ireland, Inc.Co. Clare, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 14, 2014
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AQUIOS CL FLOW CYTOMETER
- AQUIOS IMMUNO-TROL CELLS
- AQUIOS IMMUNO-TROL LOW CELLS
- AQUIOS TETRA-1 PANEL
- AQUIOS TETRA-2+ PANEL
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “aquios”. A notice may cover another product or only some lots: read it to see what it covers.
- AQUIOS IMMUNO-TROL Low Cells (2019-07-01)July 19, 2019 · Medical devices · Medical devices · Type III
- AQUIOS CL Flow Cytometer System (2018-01-29)March 2, 2018 · Medical devices · Medical devices · Type I
- AQUIOS CL FLOW CYTOMETRY SYSTEM (2017-10-02)November 28, 2017 · Medical devices · Medical devices · Type I
- Aquios Cl Flow Cytometry SystemSeptember 11, 2017 · Medical devices · Type II
- AQUIOS CL Flow CytometerMay 2, 2017 · Medical devices · Type III
- AQUIOS LYSE REAGENT KITNovember 3, 2016 · Medical devices · Type II
- Aquios Cl Flow CytometerSeptember 5, 2016 · Medical devices · Type II
- AQUIOS TETRA-2+ REAGENT KIT (2015-10-02)October 2, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.