Medical device licence · 14524 · Class 3
VIDAS IMMUNODIAGNOSTIC SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed November 17, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 14524
- Licence holder
- Biomerieux SaRockland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 17, 1999
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VIDAS - C.DIFFICILE TOXIN A & B
- VIDAS C. DIFFICILE GDH
- VIDAS HIGH SENSITIVE TROPONIN I (TNHS)
- VIDAS SYSTEM - ANALYZER CLASS 3
- VIDAS SYSTEM - C. DIFFICILE TOXIN A & B ASSAY
- VIDAS SYSTEM - CHLAMYDIA ASSAY
- VIDAS SYSTEM - CYTOMEGALOVIRUS IGG (CMVG) ASSAY
- VIDAS SYSTEM - CYTOMEGALOVIRUS IGM (CMVM) ASSAY
- VIDAS SYSTEM - RUBELLA IGG ASSAY
- VIDAS SYSTEM - TOXO IGG (TXG) ASSAY
- VIDAS SYSTEM - TOXO IGM (TXM) ASSAY
- VIDAS SYSTEM - TOXOPLASMOSIS IGG II ASSAY
- VIDAS SYSTEM - TROPONIN I ASSAY
- VIDAS SYSTEM - VIDAS NT-PROBNP2
- VIDAS TOXO IGG AVIDITY
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.