Medical device licence · 94564 · Class 4
ACCESS HIV COMBO
Yes: licensed in Canada
Licence status Issued (active); first licensed January 23, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94564
- Licence holder
- Bio-RadMarnes-La-Coquette, 51, France
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- January 23, 2015
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS HIV COMBO ASSAY
- ACCESS HIV COMBO CALIBRATOR
- ACCESS HIV COMBO QUALITY CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.