Medical device licence · 95304 · Class 3
SIMPLEXA GROUP A STREP DIRECT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 17, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95304
- Licence holder
- Diasorin Molecular LlcCypress, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- June 17, 2015
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIMPLEXA GROUP A STREP DIRECT
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
- Simplexa Covid-19 Direct AssayJanuary 10, 2022 · Medical devices · Manufacturing defect · Type II
- Simplexa Direct Amplification Disc KitDecember 13, 2021 · General hospital and personal use · Lack of efficacy · Type II
- Simplexa COVID-19 Positive Control Pack (2021-09-23)October 15, 2021 · Medical devices · Medical devices · Type II
- Simplexa Direct Detection PCR Assays (2016-02-10)March 10, 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.