ApprovalTrail

Medical device licence · 78542 · Class 3

IMMUNOCARD STAT! STREP A TEST

Yes: licensed in Canada

Licence status Issued (active); first licensed November 27, 2008. It is in Health Canada’s list of active licences.
Licence number
78542
Licence holder
Meridian Bioscience, Inc.Cincinnati, OH, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
November 27, 2008
Devices covered
1

Devices on this licence

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

  • IMMUNOCARD STAT! STREP A TEST KIT

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “immunocard”. A notice may cover another product or only some lots: read it to see what it covers.

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