Medical device licence · 68682 · Class 2
CELL-DYN SAPPHIRE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 23, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68682
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 23, 2005
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CELL-DYN 29 PLUS CONTROL (WITH RETIC)
- CELL-DYN HEMCAL PLUS CALIBRATOR
- CELL-DYN SAPPHIRE - ACCESSORY KIT
- CELL-DYN SAPPHIRE - ANALYZER
- CELL-DYN SAPPHIRE - CN-FREE HGB REAGENT
- CELL-DYN SAPPHIRE - DATA STATION
- CELL-DYN SAPPHIRE - DILUENT/SHEATH
- CELL-DYN SAPPHIRE - IMMUNO PLT REAGENT
- CELL-DYN SAPPHIRE - IMMUNO T-CELL REAGENTS
- CELL-DYN SAPPHIRE - RETICULOCYTE REAGENT
- CELL-DYN SAPPHIRE - SOFTWARE VERSION 3.0
- CELL-DYN SAPPHIRE - SOFTWARE VERSION 4.0
- CELL-DYN SAPPHIRE - SOFTWARE VERSION 5.0
- CELL-DYN SAPPHIRE - WBC 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.