Medical device licence · 3985 · Class 2
ENA ELISA TEST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 11, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 3985
- Licence holder
- Zeus Scientific, LlcBranchburg, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 11, 1999
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENA PROFILE-6 ELISA TEST
- ENA SCREEN ELISA TEST
- JO-1 ELISA TEST
- SCL-70 ELISA TEST
- SM ELISA TEST
- SM/RNP ELISA TEST
- SSA (RO) ELISA TEST
- SSB (LA) ELISA TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.