Medical device licence · 70720 · Class 3
TESTPACK PLUS STREP A WITH OBC
Yes: licensed in Canada
Licence status Issued (active); first licensed March 3, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70720
- Licence holder
- Abbott Diagnostics Medical Co., Ltd.Matsudo, 12, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- March 3, 2006
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TESTPACK PLUS STREP A WITH OBC
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 “testpack”. A notice may cover another product or only some lots: read it to see what it covers.
- ALERE TESTPACK+PLUS STREP A WITH OBC (2016-05-17)May 30, 2016 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.