ApprovalTrail

Medical device licence · 98677 · Class 3

LYRA DIRECT STREP ASSAY

No longer licensed: cancelled

Licence status Cancelled; first licensed February 23, 2017; ended January 29, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
98677
Licence holder
Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
February 23, 2017
Ended
January 29, 2018
Devices covered
1

Devices on this licence

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

  • LYRA DIRECT STREP ASSAY

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