Medical device licence · 74395 · Class 2
HDL-CHOLESTEROL
No longer licensed: cancelled
Licence status Cancelled; first licensed July 4, 2007; ended July 12, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 74395
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 4, 2007
- Ended
- July 12, 2022
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALIBRATOR HDL DIRECT
- COBAS C 111 HDL-CHOLESTEROL PLUS
- COBAS C/INTEGRA HDL-C GEN. 3
- COBAS INTEGRA HDL-C PLUS 2ND GENERATION (HDL-C)
- COBAS INTEGRA HDL-C PLUS 3RD GENERATION
- COBAS INTEGRA HDL-D 150
- HDLC3 (HDL-CHOLESTEROL PLUS 3RD GENERATION) FOR COBAS C701 ANALYZER
- HITACHI HDL-C PLUS, 3RD GENERATION
- HITACHI HDL-CHOLESTEROL (HDL-C PLUS 2ND. GENERATION)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.