Medical device licence · 77539 · Class 3
RARE POLYCLONAL ANTISERA
Yes: licensed in Canada
Licence status Issued (active); first licensed July 9, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77539
- Licence holder
- Alba Bioscience LimitedEdinburgh, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- July 9, 2008
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALBASERA ANTI-C (UPPERCASE) W (SUPERSCRIPT) INDIRECT AGGLUTININ
- ALBASERA ANTI-I (UPPERCASE) DIRECT AGGLUTININ
- ALBASERA ANTI-S (LOWERCASE) INDIRECT AGGLUTININ
- ALBASERA ANTI-W (UPPERCASE) R (LOWERCASE) A (SUPERSCRIPT) INDIRECT AGGLUT.
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.