Medical device licence · 99270 · Class 2
DIAZYME HUMAN LAMBDA FREE LIGHT CHAIN ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed June 6, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99270
- Licence holder
- Diazyme Laboratories Inc.Poway, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- June 6, 2017
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIAZYME HUMAN KAPPA/LAMBDA FLC CONTROL SET
- DIAZYME HUMAN LAMBDA (A) FREE LIGHT CHAIN ASSAY
- DIAZYME HUMAN LAMBDA (A) FREE LIGHT CHAIN, COBAS C
- DIAZYME HUMAN LAMBDA FREE LIGHT CHAIN CALIBRATOR SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.