Medical device licence · 83785 · Class 2
ALPHA-1-FETOPROTEIN (AFP)
Yes: licensed in Canada
Licence status Issued (active); first licensed August 30, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83785
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 30, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTELLIPATH FLX POLYCLONAL MOUSE ANTI-HUM ALPHA-1-FETOPROTEIN(AFP) PREDILUT
- POLYCLONAL MOUSE ANTI-HUMAN ALPHA-1-FETOPROTEIN(AFP) CONCENTRATE
- POLYCLONAL MOUSE ANTI-HUMAN ALPHA-1-FETOPROTEIN(AFP) PREDILUTE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.