Medical device licence · 64197 · Class 2
IMMAGE IMMUNOCHEMISTRY SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 19, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64197
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 19, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMAGE 800 IMMUNOCHEMISTRY SYSTEM
- RECONDITIONED IMMAGE
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 “immage”. A notice may cover another product or only some lots: read it to see what it covers.
- IMMAGE IMMUNOCHEMISTRY SYSTEM PAB, APB & LPAX (2021-02-23)March 11, 2021 · Medical devices · Medical devices · Type II
- IMMAGE Immunochemistry System (2020-04-29)May 15, 2020 · Medical devices · Medical devices · Type III
- IMMAGE Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Cal (2019-09-04)October 3, 2019 · Medical devices · Medical devices · Type III
- IMMAGE Immunochemistry System IgM Immunoglobulin M Reagent (2019-04-21)June 28, 2019 · Medical devices · Medical devices · Type III
- IMMAGE IMMUNOCHEMISTRY SYSTEMS KAPPA LIGHT CHAIN (KAP) (2017-11-03)December 8, 2017 · Medical devices · Medical devices · Type III
- Immage 800 Immunochemistry System and Reconditioned Immage (2017-02-27)June 7, 2017 · Medical devices · Medical devices · Type III
- Immage Immunochemistry Systems Immunoglobulin G Reagent (IgG)February 27, 2017 · Medical devices · Type III
- Immage Immunochamistry Systems Apolipoprotein A-1 (APA) and Beckman Coulter Clinical Chemistry Systems APO CAL (Apolipoprotein Calibrator) (2014-12-09)December 29, 2014 · Medical devices · Medical devices · Type III
- Immage Immunochemistry Systems Apolipoprotein A-1 (APA) and Apolipoprotein Calibrator (Apo Cal) (2014-03-26)April 22, 2014 · Medical devices · Medical devices · Type III
- Immage Low Concentration Immunoglobulin M (ILCIgM) (2014-02-10)March 21, 2014 · Medical devices · Medical devices · Type III
- Immage Immunochemistry System (2013-08-19)January 6, 2014 · Medical devices · Medical devices · Type III
- Immage Immunochemistry Systems Properdin Factor B and Vigil Protein Control (2013-09-18)October 31, 2013 · Medical devices · Medical devices · Type III
- Immage Immunochemistry Systems Rheumatoid Factor ReagentDecember 24, 2012 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.