Medical device licence · 300 · Class 2
VITEK 2 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 12, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 300
- Licence holder
- Biomerieux SaRockland, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 12, 1998
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VITEK 2 AST
- VITEK 2 COMPACT
- VITEK 2 SYSTEM - INSTRUMENT
- VITEK 2 SYSTEM - SUSCEPTIBILITY TEST CARDS
- VITEK 2 SYSTEM - VITEK 2 INSTRUMENT
- VITEK 2 SYSTEM - VITEK 2 XL INSTRUMENT
- VITEK COMPACT PRO
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 “vitek”. A notice may cover another product or only some lots: read it to see what it covers.
- VITEK® 2 SystemsJanuary 21, 2026 · Microbiology · Performance · Type II
- Vitek 2 Software Version 9.01/9.02July 12, 2024 · Microbiology · Performance · Type II
- Vitek 2 System - Susceptibility Test CardsApril 2, 2024 · Microbiology · Performance · Type II
- Vitek® 2 Ast-N391August 2, 2022 · Medical devices · Labelling and packaging · Type II
- VITEK MS (2019-04-19)May 17, 2019 · Medical devices · Medical devices · Type III
- VITEK 2 Test Cards (2019-01-14)February 15, 2019 · Medical devices · Medical devices · Type II
- VITEK 2 System Susceptibility and VITEK 2 Compact 30 and 60 System - Susceptibility Test Cards (2018-10-15)November 15, 2018 · Medical devices · Medical devices · Type II
- VITEK 2 Compact 30 System - Instrument (2017-03-02)April 3, 2018 · Medical devices · Medical devices · Type II
- VITEK 2 Companct 30 System - Instrument (2018-02-22)March 23, 2018 · Medical devices · Medical devices · Type II
- Vitek 2 Systems and Compact Systems (2017-11-21)December 8, 2017 · Medical devices · Medical devices · Type III
- VITEK 2 GP ID (2017-10-16)October 30, 2017 · Medical devices · Medical devices · Type II
- Vitek 2 Gp IdSeptember 11, 2017 · Medical devices · Type II
- Vitek Compact Systems (2017-04-20)June 7, 2017 · Medical devices · Medical devices · Type II
- Vitek MS PlusApril 4, 2017 · Medical devices · Type II
- VITEK 2 SYSTEM(2015-08-20)October 8, 2015 · Medical devices · Health products · Type II
- Softwares for VITEK Systems (2015-02-17)May 21, 2015 · Medical devices · Health products · Type III
- VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C (2015-03-30)April 30, 2015 · Medical devices · Health products · Type II
- VITEK 2 Compact 30 System - Instrument, VITEK 2 Compact 60 System - Instrument, VITEK 2 System - VITEK 2 XL Instrument (2015-01-07)February 20, 2015 · Medical devices · Health products · Type II
- Vitek MS Plus (2014-09-04)October 1, 2014 · Medical devices · Medical devices · Type II
- Vitek 2 GN Card (2014-07-29)August 15, 2014 · Medical devices · Medical devices · Type III
- Vitek MS-CHCA Matrix and Vitek MS-DS Target Slides (2014-02-27)April 4, 2014 · Medical devices · Medical devices · Type III
- Vitek 2, Vitek 2 Compact 30, and Vitek 2 Compact 60 system susceptibility test cards (2013-12-23)February 11, 2014 · Medical devices · Medical devices · Type III
- Vitek MS (2013-10-07)November 25, 2013 · Medical devices · Medical devices · Type II
- VITEK 2 AST-GN27 CardFebruary 4, 2013 · Medical devices · Type II
- Vitek MSNovember 26, 2012 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.