ApprovalTrail

Medical device licence · 85070 · Class 2

LIPOPROTEIN (A) TEST KITS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed February 3, 2011; ended October 31, 2014. It is in Health Canada’s archive of licences no longer in force.
Licence number
85070
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
February 3, 2011
Ended
October 31, 2014
Devices covered
3

Devices on this licence

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

  • LIPOPROTEIN (A) (TINA-QUANT LIPOPROTEIN (A) FOR ROCHE/HITACHI AND MODULAR P ANALYZERS)
  • LPALX (TINA-QUANT LIPOPROTEIN (A) (LATEX) FOR CABAS C 311 AND COBAS C 501/502)
  • LPALX (TINA-QUANT LIPOPROTEIN (A) (LATEX) FOR COBRAS C 701 SYSTEM)

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