Medical device licence · 100603 · Class 2
SYVA EMIT II PLUS OXYCODONE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 16, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100603
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 16, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMIT II PLUS OXYCODONE ASSAY
- EMIT II PLUS OXYCODONE NEGATIVE CONTROL
- EMIT II PLUS OXYCODONE POSITIVE CONTROL
- EMIT II PLUS SPECIALTY MULTI DRUG CALIBRATOR/CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.