Medical device licence · 38944 · Class 2
PTH TEST KIT (PARATHYROID HORMONE)
Yes: licensed in Canada
Licence status Issued (active); first licensed March 30, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 38944
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 30, 2000
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALSET II PTH
- CALSET PTH STAT
- ELECSYS PTH (PARATHYROID HORMONE)
- ELECSYS PTH STAT
- PTH (1-84) CALSET
- PTH CALSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.