Medical device licence · 12211 · Class 2
VIDAS SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed September 27, 1999; ended October 31, 2001. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 12211
- Licence holder
- Biomerieux SaRockland, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 27, 1999
- Ended
- October 31, 2001
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VIDAS CDA II
- VIDAS MUMPS IGG (MPG)
- VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
- VIDAS ROTAVIRUS (RTV)
- VIDAS T-UPTAKE
- VIDAS THEOPHYLLINE (THEO)
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 “vidas”. A notice may cover another product or only some lots: read it to see what it covers.
- Vidas High Sensitive Troponin I (Tnhs)February 21, 2022 · Chemistry · Software defect · Type II
- Vidas® Cmv Igm (Ref. 30205)February 14, 2022 · Chemistry · Software defect · Type II
- VIDAS Protein C & TOXO IGG AvidityNovember 5, 2021 · Medical devices · Performance · Type III
- Vidas products (2021-09-26)October 8, 2021 · Medical devices · Medical devices · Type II
- VIDAS - Varicella-Zoster Virus (VZG) Assay (2019-11-28)December 13, 2019 · Medical devices · Medical devices · Type II
- VIDAS SYSTEM - Analyzer Class 3 and miniVIDAS Analyzer (2018-01-10)February 22, 2018 · Medical devices · Medical devices · Type II
- VIDAS TOXO IGG AVIDITY (2016-08-09)August 26, 2016 · Medical devices · Medical devices · Type III
- VIDAS - ESTRADIOL II ASSAY (2016-07-12)August 5, 2016 · Medical devices · Medical devices · Type II
- VIDAS SYSTEM - TOXO IGM (TXM) ASSAY (2016-02-08)April 7, 2016 · Medical devices · Medical devices · Type II
- VIDAS LYME IGG II (2016-03-14)April 4, 2016 · Medical devices · Medical devices · Type III
- VIDAS - PROGESTERONE ASSAY (2014-11-25)April 13, 2015 · Medical devices · Medical devices · Type III
- Vidas D-Dimer Exclusion II Ref 30455January 21, 2013 · Medical devices · Type I
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.