Medical device licence · 68331 · Class 2
FLOW CYTOMETRY HEMATOLOGY CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 6, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68331
- Licence holder
- R & D Systems, IncMinneapolis, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 6, 2005
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LEUKOREDUCED RBC/PLT
- STATUSFLOW
- STATUSFLOW LO
- STATUSFLOW PRO
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.