Medical device licence · 1015 · Class 2
CELL-DYN 4000 SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed February 2, 1999; ended October 25, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 1015
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 2, 1999
- Ended
- October 25, 2010
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CELL-DYN 4000 SYSTEM - AEM CALIBRATOR
- CELL-DYN 4000 SYSTEM - CELL-DYN 29 PLUS CONTROL ASSAY DISK
- CELL-DYN 4000 SYSTEM - CELL-DYN 29 PLUS CONTROL WITH RETIC
- CELL-DYN 4000 SYSTEM - CELL-DYN 29 RETIC PLUS CONTROL
- CELL-DYN 4000 SYSTEM - CONTROL
- CELL-DYN 4000 SYSTEM - HGB REAGENT
- CELL-DYN 4000 SYSTEM - IMMUNO PLATELET
- CELL-DYN 4000 SYSTEM - IMMUNO T-CELL (CD3/4/8) REAGENTS
- CELL-DYN 4000 SYSTEM - INSTRUMENT
- CELL-DYN 4000 SYSTEM - INSTRUMENT SOFTWARE
- CELL-DYN 4000 SYSTEM - RETIC CELL COUNT
- CELL-DYN 4000 SYSTEM - SHEATH/DILUENT
- CELL-DYN 4000 SYSTEM - WHITE BLOOD CELL COUNT REAGENT
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 “cell-dyn”. A notice may cover another product or only some lots: read it to see what it covers.
- CELL-DYN Emerald System - Instrument (2019-02-26)March 15, 2019 · Medical devices · Medical devices · Type II
- CELL-DYN Ruby (2017-11-22)November 30, 2017 · Medical devices · Medical devices · Type III
- CELL-DYN EMERALD SYSTEM - CLEANER REAGENT (2016-03-29)July 4, 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.