Medical device licence · 60604 · Class 3
TISSUE TYPING TRAYS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 1, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 60604
- Licence holder
- One Lambda IncWest Hills, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- October 1, 2002
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LAMBDA MONOCLONAL HLA CLASS I AND CLASS II TISSUE TYPING TRAYS
- TERASAKI HLA CLASS I AND CLASS II DRY TISSUE TYPING TRAYS
- TERASAKI HLA TISSUE TYPING TRAY
- TERASAKI SPECIAL HLA TISSUE TYPING TRAYS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.