Medical device licence · 11059 · Class 3
FETALSCREEN
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 31, 1999; ended September 4, 2007. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 11059
- Licence holder
- Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- August 31, 1999
- Ended
- September 4, 2007
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FETALSCREEN TEST FOR D(RHO) POSITIVE FETAL RED BLOOD CELLS
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “fetalscreen”. A notice may cover another product or only some lots: read it to see what it covers.
- Fetalscreen IIAugust 15, 2024 · Haematology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.