Medical device licence · 36845 · Class 2
HDL-CHOLESTEROL
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 18, 2002; ended October 13, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 36845
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 18, 2002
- Ended
- October 13, 2020
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECT HDL CHOLESTEROL (HDL) HITACHI 917, HITACHI MODULAR P
- DIRECT HDL-CHOLESTEROL (LIQUID) CLEAR. METHOD, COBAS/HITACHI/SYNCHRON CX/LX
- DIRECT HDL-CHOLESTEROL CLEARANCE METHOD HITACHI 737/747, HITACHI MODULAR D
- DIRECT HDL-CHOLESTEROL CLEARANCE METHOD, DIMENSION
- DIRECT HDL-CHOLESTEROL CLEARANCE METHOD, HITACHI 747
- DIRECT HDL-CHOLESTEROL CLEARANCE METHOD, RX DAYTONA
- DIRECT HDL-CHOLESTEROL CLEARANCE METHOD, SYNCHRON CX/LX
- DIRECT HDL-CHOLESTEROL PEGME METHOD AUTO. & MANUAL HITACHI/SYNCHRON CX/LX
- HDL-CHOLESTEROL (LIQUID) PHOSPHOTUNG METHOD, GENERIC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.