Medical device licence · 60561 · Class 2
ABSOLUTE COUNT REAGENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 24, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 60561
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 24, 2002
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COULTER MANUAL CD4 COUNT KIT
- FLOW-COUNT FLUOROSPHERES- ABSOLUTE CELL COUNT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.