ApprovalTrail

Medical device licence · 95059 · Class 3

COBAS MRSA/SA TEST

Yes: licensed in Canada

Licence status Issued (active); first licensed April 28, 2015. It is in Health Canada’s list of active licences.
Licence number
95059
Licence holder
Roche Molecular Systems, IncBranchburg, NJ, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
April 28, 2015
Devices covered
1

Devices on this licence

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

  • COBAS 4800 MRSA/SA TEST

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