Medical device licence · 15633 · Class 3
ACCESS IMMUNOASSAY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 7, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 15633
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 7, 2000
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS ACCUTNI+3 CALIBRATORS
- ACCESS ACCUTNI+3 REAGENT
- ACCESS AFP REAGENTS
- ACCESS HYBRITECH FREE PSA REAGENTS
- ACCESS HYBRITECH PSA/CAL/DIL/QC
- ACCESS IMMUNOASSAY ANALYZERS - CLASS 3
- ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3
- ACCESS IMMUNOASSAY SYSTEM - BR MONITOR (CA 15-3) ASSAY
- ACCESS IMMUNOASSAY SYSTEM - CK-MB ASSAY
- ACCESS IMMUNOASSAY SYSTEM - CMV IGG ASSAY
- ACCESS IMMUNOASSAY SYSTEM - CMV IGM ASSAY
- ACCESS IMMUNOASSAY SYSTEM - GI MONITOR (CA 19-9)
- ACCESS IMMUNOASSAY SYSTEM - MYOGLOBIN ASSAY
- ACCESS IMMUNOASSAY SYSTEM - OV MONITOR (CA125) ASSAY
- ACCESS IMMUNOASSAY SYSTEM - WASH BUFFERS
- ACCESS RUBELLA IGG ASSAY
- ACCESS RUBELLA IGM ASSAY
- ACCESS SYSTEM - AFP ASSAY
- ACCESS SYSTEM - CEA ASSAY
- ACCESS TOXO IGG REAGENTS
- ACCESS TOXO IGM ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.