Medical device licence · 69528 · Class 3
I-STAT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 18, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69528
- Licence holder
- Abbott Point Of Care Inc.Abbott Park, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 18, 2005
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- I-STAT 1 9V NIMH BATTERY
- I-STAT 1 ANALYZER
- I-STAT 1 ANALYZER SYSTEM - SYSTEM CONTROLS
- I-STAT 6+ CARTRIDGE
- I-STAT ALINITY INSTRUMENT
- I-STAT ALINITY RECHARGEABLE BATTERY
- I-STAT BNP CARTRIDGE AND CONTROLS
- I-STAT CALIBRATION VERIFICATION
- I-STAT CELITE ACT CARTRIDGE AND CONTROLS
- I-STAT CG4+ CARTRIDGE
- I-STAT CG8+ CARTRIDGE
- I-STAT CHEM8+ CARTRIDGE AND CONTROLS
- I-STAT CK-MB CARTRIDGE
- I-STAT CREA CARTRIDGE
- I-STAT CTNI CARTRIDGE, CONTROLS, AND CALIBRATORS
- I-STAT E3+ CARTRIDGE
- I-STAT EC4+ CARTRIDGE
- I-STAT EC8+ CARTRIDGE
- I-STAT EG6+ CARTRIDGE
- I-STAT EG7+ CARTRIDGE
- I-STAT ELECTRONIC SIMULATOR
- I-STAT G CARTRIDGE
- I-STAT G3+ CARTRIDGE
- I-STAT KAOLIN ACT CARTRIDGE
- I-STAT PT/INR CARTRIDGE AND CONTROLS
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 “i-stat”. A notice may cover another product or only some lots: read it to see what it covers.
- I-STAT CARTRIDGE (2020-12-22)January 15, 2021 · Medical devices · Medical devices · Type II
- i-STAT CG4+, G3+ & CHEM8+cartridges (blue) (2020-02-04)February 28, 2020 · Medical devices · Medical devices · Type III
- i-STAT CHEM8+ Cartridges and Controls (2018-06-05)June 14, 2018 · Medical devices · Medical devices · Type III
- i-STAT Alinity Instrument with Analyzer Software (2017-12-21)January 29, 2018 · Medical devices · Medical devices · Type III
- i-STAT Kaolin ACT Cartridge (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type III
- I-STAT 1 ANALYZER (SOFTWARE) (2017-11-09)November 30, 2017 · Medical devices · Medical devices · Type III
- I-Stat Analyzer Software and Cartridges (2017-02-10)March 16, 2017 · Medical devices · Medical devices · Type III
- I-stat 1 Analyzer system - G3+ Cartridge (2014-01-30)March 20, 2014 · Medical devices · Medical devices · Type II
- I-Stat 1 Analyzer System - PT/LNR Cartridge and Controls (2013-10-28)December 4, 2013 · 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.