Medical device licence · 2193 · Class 2
CRYOCHECK REFERENCE CONTROL PLASMAS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 1, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 2193
- Licence holder
- Precision Biologic Inc.Dartmouth, NS, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- April 1, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CRYOCHECK ABNORMAL 1 REFERENCE CONTROL
- CRYOCHECK ABNORMAL 2 REFERENCE CONTROL
- CRYOCHECK REFERENCE CONTROL NORMAL
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “cryocheck”. A notice may cover another product or only some lots: read it to see what it covers.
- CRYOcheck Lupus Positive Control (2019-01-08)January 25, 2019 · Medical devices · Medical devices · Type III
- CRYOcheck Factor II Deficient Plasma (2017-12-07)January 8, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.