Medical device licence · 85800 · Class 2
CHOLESTEROL REAGENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 13, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85800
- Licence holder
- Horiba Instruments Inc Adba: Horiba Medical, Pointe, Pointe Scientific, And Clintox BrandsCanton, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 13, 2011
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CHOLESTEROL REAGENT SET (DRY POWDER)
- CHOLESTEROL REAGENT SET (LIQUID FOR HITACHI 704)
- CHOLESTEROL REAGENT SET (LIQUID FOR HITACHI 717, 917)
- CHOLESTEROL REAGENT SET (LIQUID FOR HITACHI 747)
- CHOLESTEROL REAGENT SET (LIQUID FOR HITACHI 917/MODULAR)
- CHOLESTEROL REAGENT SET (LIQUID FOR MINDRAY)
- CHOLESTEROL REAGENT SET (LIQUID)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.