Medical device licence · 78483 · Class 2
XPECT ROTAVIRUS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 19, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78483
- Licence holder
- Remel Inc.Lenexa, KS, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 19, 2008
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- XPECT ROTAVIRUS
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 “xpect”. A notice may cover another product or only some lots: read it to see what it covers.
- Xpect Clostridium Difficile ToxinDecember 10, 2012 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.