Medical device licence · 12966 · Class 3
AMNIOSTAT-FLM-PG
No longer licensed: cancelled
Licence status Cancelled; first licensed October 8, 1999; ended May 22, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 12966
- Licence holder
- Irvine Scientific, LlcSanta Ana, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- October 8, 1999
- Ended
- May 22, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMNIOSTAT-FLM (FETAL LUNG MATURITY) KIT
- AMNIOSTAT-FLM-PG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.