Medical device licence · 69255 · Class 2
TDM/B-HYDROXYBUTYRATE LINEARITY STANDARDS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69255
- Licence holder
- Ekf Diagnostics,Inc, Ata Standbio Laboratory, Llc, Separation Tech, Inc, And Ekf Life Sci.Boerne, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- September 14, 2005
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TDM/B-HYDROXYBUTYRATE LINEARITY STANDARDS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.