Medical device licence · 60372 · Class 3
FAST PACK PSA IMMUNOASSAY SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed August 27, 2002; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60372
- Licence holder
- Qualigen Inc.Carlsbad, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 27, 2002
- Ended
- February 16, 2004
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FAST PACK PSA IMMUNOASSAY SYSTEM - ANALYZER
- FAST PACK PSA IMMUNOASSAY SYSTEM - CALIBRATOR KIT
- FAST PACK PSA IMMUNOASSAY SYSTEM - CONTROL KIT
- FAST PACK PSA IMMUNOASSAY SYSTEM - PSA ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.