Medical device licence · 27204 · Class 2
QUICKVUE HCG COMBO TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed January 26, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 27204
- Licence holder
- Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 26, 2001
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- QUICKVUE HCG COMBO TEST
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.
- QuickVue® Dipstick Strep A TestApril 10, 2026 · Microbiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.