ApprovalTrail

Medical device licence · 29260 · Class 3

QUICKVUE STREP A TEST KITS

Yes: licensed in Canada

Licence status Issued (active); first licensed May 8, 2001. It is in Health Canada’s list of active licences.
Licence number
29260
Licence holder
Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
May 8, 2001
Devices covered
4

Devices on this licence

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

  • QUICKVUE DIPSTICK STREP A TEST
  • QUICKVUE IN-LINE STREP A TEST
  • QUICKVUE STREP A LIQUID CONTROL SET
  • QUICKVUE+ STREP A

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 “quickvue”. 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.