Medical device licence · 7323 · Class 2
IMMAGE IMMUNOCHEMISTRY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 6, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 7323
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 6, 1999
- Devices covered
- 34
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMAE IMMUNOCHEMISTRY SYSTEM IGM IMMUNOGLOBULIN M REAGENT
- IMMAGE IMMUNCHEMISTRY SYSTEM APA APOLIPOPROTEIN A-1 REAGENT
- IMMAGE IMMUNOCHEMISTRY ANALYZER - CLASS 2
- IMMAGE IMMUNOCHEMISTRY SYSTEM A1M ALPHA-1-MICROGLOBULIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM AAG ALPHA-1-ACID GLYCOPROTEIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM AAT ALPHA-1-ANTITRYPSIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM ALB ALBUMIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM APB APOLIPOPROTEIN B REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM ASO ANTISTREPTOLYSIN O REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM C3 COMPLEMENT C3 REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM C4 COMPLEMENT C4 REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM CER CERULOPLASMIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM CRP C-REACTIVE PROTEIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENS. CARDIAC C-REACTIVE PROTEIN ASSAY
- IMMAGE IMMUNOCHEMISTRY SYSTEM HPT HAPTOGLOBIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM IGA IMMUNOGLOBULIN A REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM IGG IMMUNOGLOBULIN G REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM IGU URINE IMMUNOGLOBULIN G REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM KAP KAPPA LIGHT CHAIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM LAM LAMBDA LIGHT CHAIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM MA MICROALBUMIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM PAB PREALBUMIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM PFB PROPERDIN FACTOR B REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM TOTAL IMMUNOGLOBULIN E (IGE) REAGENT AND CAL.
- IMMAGE IMMUNOCHEMISTRY SYSTEM TRF TRANSFERRIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEM TRU URINE TRANSFERRIN REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEMS ALPHA-2-MACROGLOBULIN (AMG) REAGENT
- IMMAGE IMMUNOCHEMISTRY SYSTEMS ANTITHROMBIN III (AT3) REAGENT
- IMMAGE LIPOPROTEIN(A) (LPAX) REAGENT
- IMMAGE LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- IMMAGE LOW CONCENTRATION IMMUNOGLOBULIN M REAGENT
- IMMAGE SYSTEMS ANTI-DEOXYRIBONUCLEASE B (DNB) ASSAY
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.