Medical device licence · 75159 · Class 2
AMACR, CLONE 13H4
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
- 75159
- 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
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEX MONOCLONAL RABBIT ANTI-HUMAN AMACR, CLONE 13H4
- MONOCLONAL RABBIT ANTI-HUMAN AMACR, CLONE 13H4, READY-TO-USE
- MONOCLONAL RABBIT ANTI-HUMAN AMACR, CLONE 13HR
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 “amacr”. A notice may cover another product or only some lots: read it to see what it covers.
- ALPHA-METHYLACYL-COA RACEMASE (AMACR P504S) and BONDS READY-TO-USE (2015-12-15)January 22, 2016 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.