Medical device licence · 77774 · Class 4
SYPHILIS EIA II (DONOR SCREENING)
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 13, 2008; ended October 26, 2021. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 77774
- Licence holder
- Trinity Biotech UsaJamestown, NY, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- August 13, 2008
- Ended
- October 26, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIORAD SYPHILIS EIA II TOTAL ANTIBODY
- CAPTIA SYPHILIS TA EIA
- LAB21 SYPHILIS TOTAL ANTIBODY EIA
- SYPHILIS EIA II (DONOR SCREENING)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.