ApprovalTrail

Medical device licence · 38983 · Class 2

FERRITIN TEST KIT

Yes: licensed in Canada

Licence status Issued (active); first licensed January 11, 1999. It is in Health Canada’s list of active licences.
Licence number
38983
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
January 11, 1999
Devices covered
4

Devices on this licence

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

  • ELECSYS FERRITIN
  • FERR4 (TINA-QUANT FERRITIN GEN. 4)
  • FERR4 (TINA-QUANT FERRITIN GEN.4) FOR COBAS C701 ANALYZER
  • FERRITIN GEN.2 FOR USE ON COBAS INTEGRA ANALYZERS

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