ApprovalTrail

Medical device licence · 74385 · Class 2

LDL-CHOLESTEROL

No longer licensed: cancelled

Licence status Cancelled; first licensed July 5, 2007; ended July 12, 2022. It is in Health Canada’s archive of licences no longer in force.
Licence number
74385
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
July 5, 2007
Ended
July 12, 2022
Devices covered
4

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • COBAS C 111 LDL-CHOLESTEROL (LDL_C)
  • HITACHI LDL-C PLUS
  • HITACHI LDL-CHOLESTEROL, NO PRETREATMENT, LDL-C PLUS 2ND GEN.
  • LDL-C (LDL-CHOLESTEROL PLUS 2ND GENERATION) FOR COBAS C701 ANALYZER

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.