Medical device licence · 97004 · Class 2
CELL-DYN EMERALD 22 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 26, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97004
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 26, 2016
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CELL-DYN 22 PLUS CALIBRATOR
- CELL-DYN 22 PLUS CONTROL
- CELL-DYN EMERALD 22
- CELL-DYN EMERALD 22 AL SYSTEM
- CELL-DYN EMERALD 22 AL SYSTEM SOFTWARE
- CELL-DYN EMERALD 22 DILUENT
- CELL-DYN EMERALD 22 EASY CLEANER
- CELL-DYN EMERALD 22 LYSE
- CELL-DYN EMERALD 22 SOFTWARE
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.