Medical device licence · 63370 · Class 3
LABSCREEN
Yes: licensed in Canada
Licence status Issued (active); first licensed December 9, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 63370
- Licence holder
- One Lambda IncWest Hills, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 9, 2003
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LABSCREEN CLASS I & II SINGLE ANTIGEN
- LABSCREEN PRA CLASS I
- LABSCREEN PRA CLASS I & II
- LABSCREEN PRA CLASS I & II MIXED
- LABSCREEN PRA CLASS II
- LABSCREEN SINGLE ANTIGEN HLA CLASS I EXPLEX
- LABSCREEN SINGLE ANTIGEN HLA CLASS II EXPLEX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.