Medical device licence · 61471 · Class 2
ANA TEST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 14, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 61471
- Licence holder
- Immuno Concepts N.A., LtdSacramento, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 14, 2003
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANA TEST SYSTEM (HEP-2 COLORZYME)
- ANA TEST SYSTEM (HEP-2 FLUORESCENT)
- ANA TEST SYSTEM (HEP-2000 COLORZYME)
- ANA TEST SYSTEM (HEP-2000 FLUORESCENT)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.