Medical device licence · 1370 · Class 2
ESTRONE ELISA
Yes: licensed in Canada
Licence status Issued (active); first licensed February 16, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 1370
- Licence holder
- Diagnostics Biochem Canada Inc.London, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 16, 1999
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ESTRONE ELISA
- ESTRONE ELISA CAL A
- ESTRONE ELISA CAL B
- ESTRONE ELISA CAL C
- ESTRONE ELISA CAL D
- ESTRONE ELISA CAL E
- ESTRONE ELISA CAL F
- ESTRONE ELISA CONTROL 1
- ESTRONE ELISA CONTROL 2
- ESTRONE ELISA HRP CONJ
- ESTRONE ELISA MPL
- STOP
- TMB SUB
- WASH BUFF CONC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.