Medical device licence · 22387 · Class 2
VITROS IMMUNODIAGNOSTIC SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed July 25, 2000; ended October 29, 2003. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 22387
- Licence holder
- Fujirebio Diagnostics, Inc.Malvern, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 25, 2000
- 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 PRODUCTS CA 19-9 REAGENT PACK - CALIBRATOR
- VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA 15-3 REAGENT PACK - CALIBRATOR
- VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.