Medical device licence · 113735 · Class 2
PRIME SCREEN MULTI-PANEL URINE TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed July 30, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113735
- Licence holder
- Wondfo Usa Co., Ltd.Bolingbrook, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 30, 2025
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRIME SCREEN MULTI-PANEL URINE TEST
- PRIME SCREEN SINGLE PANEL URINE TEST CANNABINOIDS (THC)
- PRIME SCREEN SINGLE PANEL URINE TEST COCAINE (COC)
- PRIME SCREEN SINGLE PANEL URINE TEST COTININE (COT)
- PRIME SCREEN SINGLE PANEL URINE TEST ETHYL GLUCURONIDE (ETG)
- PRIME SCREEN SINGLE PANEL URINE TEST FENTANYL (FTY)
- PRIME SCREEN SINGLE PANEL URINE TEST METHAMPHETAMINE (MAMP/MET 500)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.