Medical device licence · 98820 · Class 3
AMPLICHEK II
Yes: licensed in Canada
Licence status Issued (active); first licensed March 16, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98820
- Licence holder
- Bio-Rad Laboratories, Inc.Irvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- March 16, 2017
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPLICHEK II LEVEL 1
- AMPLICHEK II LEVEL 1 MINIPAK
- AMPLICHEK II LEVEL 2
- AMPLICHEK II LEVEL 2 MINIPAK
- AMPLICHEK II LEVEL 3
- AMPLICHEK II LEVEL 3 MINIPAK
- AMPLICHEK II LEVEL NEGATIVE
- AMPLICHEK II LEVEL NEGATIVE MINIPAK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.