Medical device licence · 61047 · Class 3
APTIMA COMBO 2 ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed November 27, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 61047
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- November 27, 2002
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- APTIMA COMBO 2 ASSAY
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 “aptima”. A notice may cover another product or only some lots: read it to see what it covers.
- Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay SoftwareJune 11, 2026 · Immunology · Unauthorised device · Type II
- Aptima® CMV Quant AssayDecember 6, 2023 · Immunology · Performance · Type II
- Aptima HIV-1 Quant Assay (2020-12-15)January 15, 2021 · Health products · Medical devices · Type II
- APTIMA Urine Specimen Collection Kit (2014-04-17)January 9, 2015 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.