Medical device licence · 115342 · Class 2
ALEGRIA FLASH ENA SCREEN
Yes: licensed in Canada
Licence status Issued (active); first licensed May 5, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115342
- Licence holder
- Zeus Scientific, LlcBranchburg, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 5, 2026
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALEGRIA FLASH ENA SCREEN ASSAY
- ALEGRIA FLASH ENA SCREEN CALIBRATOR 1
- ALEGRIA FLASH ENA SCREEN CALIBRATOR 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.