Medical device licence · 15091 · Class 2
BACTEC MGIT 960 KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 15091
- Licence holder
- Becton Dickinson And Company (Bd)Sparks, MD, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- December 8, 1999
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BACTEC MGIT 960 IR KIT
- BACTEC MGIT 960 SIRE KIT
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 “bactec”. A notice may cover another product or only some lots: read it to see what it covers.
- BD BACTEC™ MGIT™ 960 PZA KitNovember 14, 2025 · Microbiology · Labelling and packaging · Type II
- BD BACTEC MGIT 960 PZA Kit And Susceptibility Test MediumJuly 31, 2024 · Microbiology · Sterility · Type II
- Becton Dickinson Bactec FX System, Bottom (2013-12-10)January 16, 2014 · 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.