Medical device licence · 75161 · Class 2
PROSTATE-SPECIFIC MEMBRANE ANTIGEN
Yes: licensed in Canada
Licence status Issued (active); first licensed October 19, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75161
- Licence holder
- Agilent Technologies, Inc.Lake Forest, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 19, 2007
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEX MONOCLONAL MOUSE ANTI-HUMAN PROSTATE SPECIFIC MEMBRANE NTIGEN, CLONE 3E6, READY-TO-USE(LINK)
- MONOCLONAL MOUSE ANTI-HUMAN PROSTATE-SPECIFIC MEMBRANE ANTIGEN READY-TO-USE
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 “prostate-specific”. A notice may cover another product or only some lots: read it to see what it covers.
- IMMULITE and IMMULITE 1000 System- Prostate-Specific Antigen (PSA) Assay (2018-07-19)July 27, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.