Medical device licence · 102109 · Class 2
IN-VITRO TRANSCRIPT (IVT) CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 28, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 102109
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 28, 2018
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- (BKV) PLASMID CONTROL
- (CMV) PLASMID CONTROL
- (EBV) PLASMID CONTROL
- (GAS) PLASMID CONTROL
- (VZV) PLASMID CONTROL
- NG RES C272T IVT CONTROL
- NG WT IVT CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.