Medical device licence · 94178 · Class 2
WHOLE BLOOD CONTROL
Yes: licensed in Canada
Licence status Issued (active); first licensed November 5, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94178
- Licence holder
- Utak Laboratories Inc.Valencia, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 5, 2014
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLOOD LEAD
- CUSTOM WHOLE BLOOD CONTROL
- DRUGS OF ABUSE LEVEL 1
- DRUGS OF ABUSE LEVEL 2
- ETHANOL 80
- ETHANOL WHOLE BLOOD TRI LEVEL SET
- FENTANYL ANALOGUES WHOLE BLOOD CONTROL
- LYOPHILIZED WHOLE BLOOD TRACE ELEMENTS - VOLATILES
- METALS WHOLE BLOOD
- WHOLE BLOOD CONTROL
- WHOLE BLOOD TOXICOLOGY CONTROL - BENZODIAZEPINES PLUS
- WHOLE BLOOD TOXICOLOGY CONTROL - IMMUNOSUPPRESSANTS
- WHOLE BLOOD TOXICOLOGY CONTROL - PM 100
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.