ApprovalTrail

Medical device licence · 99380 · Class 3

SOLANA C. DIFFICILE ASSAY

Yes: licensed in Canada

Licence status Issued (active); first licensed July 11, 2017. It is in Health Canada’s list of active licences.
Licence number
99380
Licence holder
Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
July 11, 2017
Devices covered
1

Devices on this licence

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

  • SOLANA C. DIFFICILE ASSAY

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