Medical device licence · 62402 · Class 3
CHOLESTECH GDX SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed May 6, 2003; ended November 5, 2009. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 62402
- Licence holder
- Cholestech CorporationHayward, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 6, 2003
- Ended
- November 5, 2009
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CHOLESTECH GDX A1C CONTROLS
- CHOLESTECH GDX A1C TEST CARTRIDGES
- CHOLESTECH GDX ANALYZER
- CHOLESTECH GDX OPTICS CHECK CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.