Medical device licence · 108596 · Class 3
SIMPLEXA GBS DIRECT
Yes: licensed in Canada
Licence status Issued (active); first licensed December 1, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108596
- Licence holder
- Diasorin Molecular LlcCypress, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 1, 2022
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIMPLEXA DIRECT AMPLIFICATION DISC
- SIMPLEXA GBS DIRECT
- SIMPLEXA GBS DIRECT POSITIVE CONTROL
- SIMPLEXA GBS DIRECT REACTION MIX
- SIMPLEXA GBS POSITIVE CONTROL PACK
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 “simplexa”. A notice may cover another product or only some lots: read it to see what it covers.
- Simplexa Direct Amplification Disc KitJuly 4, 2023 · Microbiology · Performance · Type II
- Simplexa Flu A/B & RSV DirectFebruary 10, 2023 · Microbiology · Performance · Type II
- Simplexa Covid-19 DirectFebruary 9, 2023 · Microbiology · Performance - COVID · Type II
- Simplexa Covid-19 & Flu A/B DirectFebruary 9, 2023 · Pathology · Performance - COVID · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.