Medical device licence · 89062 · Class 4
ACCESS 2 IMMUNOASSAY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 20, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89062
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- June 20, 2012
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS2 IMMUNOASSAY SYSTEM
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AB ASSAY
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AB CALIBATORS
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AB QC
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AG ASSAY
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AG CALIBRATORS
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AG CONFIRMATORY ASSAY
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS HBS AG QC
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS SUBSTRATE
- ACCESS2 IMMUNOASSAY SYSTEM - ACCESS WASH BUFFERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.