Medical device licence · 89424 · Class 3
FASTPACK IP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 9, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89424
- Licence holder
- Qualigen Inc.Carlsbad, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 9, 2012
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DESKTOP POWER SUPPLY FOR USE WITH FASTPACK IP ANALYZER
- FASTPACK IP ANALYZER
- FASTPACK IP ANALYZER, REFURBISHED
- FASTPACK IP ANALYZER, UPGRADE
- FASTPACK IP TOTAL PSA IMMUNOASSAY
- FASTPACK TOTAL PSA CALIBRATOR
- FASTPACK TOTAL PSA CONTROL
- GILSON PIPETTE FOR USE WITH FASTPACK SYSTEM
- GILSON TIPS FOR USE WITH FASTPACK SYSTEM
- POWER CORD FOR USE WITH FASTPACK IP ANALYZER
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 “fastpack”. A notice may cover another product or only some lots: read it to see what it covers.
- Fastpack IP Vitamin D ImmunoassayJuly 18, 2017 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.