Medical device licence · 60547 · Class 3
VITROS IMMUNODIAGNOSTIC SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed September 23, 2002; ended October 29, 2003. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60547
- Licence holder
- Fujirebio Diagnostics, Inc.Malvern, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 23, 2002
- Ended
- October 29, 2003
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA 15-3 REAGENT PACK - CALIBRATOR
- VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR
- VITROS ECI IMMUNODIAGNOSTIC SYSTEM - PSA REAGENT PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.