Medical device licence · 94556 · Class 2
DURACLONE B27
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 19, 2015; ended September 5, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 94556
- Licence holder
- Beckman Coulter India Pvt LtdBangalore, KA, India
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 19, 2015
- Ended
- September 5, 2022
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DURACLONE B27 REAGENT 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 “duraclone”. A notice may cover another product or only some lots: read it to see what it covers.
- Duraclone B27 Reagent KitJune 7, 2022 · Medical devices · Performance · Type II
- DURACLONE B27 REAGENT KIT (2017-12-11)December 21, 2017 · Medical devices · Medical devices · Type II
- DURACLONE B27 (2016-05-02)May 16, 2016 · 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.