Medical device licence · 85594 · Class 2
OSOM HCG SERUM CONTROL SET
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85594
- Licence holder
- Sekisui Diagnostics, LlcLexington, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 24, 2011
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSOM HCG SERUM CONTROL SET
- OSOM HCG SERUM NEGATIVE CONTROL
- OSOM HCG SERUM POSITIVE CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.