Medical device licence · 36846 · Class 2
LDL-CHOLESTEROL
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 18, 2002; ended October 25, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 36846
- 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 25, 2019
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECT LDL-CHOLESTEROL - ENZYMATIC CLEARANCE METHOD FOR HITACHI 917
- DIRECT LDL-CHOLESTEROL CLEARANCE METHOD, COBAS/HITACHI/SYNCHRON CX/LX
- DIRECT LDL-CHOLESTEROL CLEARANCE METHOD, DIMENSION
- DIRECT LDL-CHOLESTEROL CLEARANCE METHOD, HITACHI 737/747, HITACHI MODULAR D
- DIRECT LDL-CHOLESTEROL CLEARANCE METHOD, RX DAYTONA
- DIRECT LDL-CHOLESTEROL ENZYMEMATIC CLEARANCE METHOD
- LDL-CHOLESTEROL HEPARIN METHOD, GENERIC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.