Medical device licence · 71604 · Class 2
THROMBOTYPE 1
Yes: licensed in Canada
Licence status Issued (active); first licensed June 13, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71604
- Licence holder
- Immucor Gti Diagnostics, Inc.Waukesha, WI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- June 13, 2006
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- THROMBOTYPE 1
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 “thrombotype”. A notice may cover another product or only some lots: read it to see what it covers.
- ThromboType (2018-07-05)July 19, 2018 · Medical devices · Medical devices · Type III
- THROMBOTYPE 1 (2017-09-21)October 20, 2017 · 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.