Medical device licence · 61756 · Class 3
PROBNP KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 61756
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- February 6, 2003
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIAC CONTROL PROBNP FOR COBAS H232
- ROCHE CARDIAC PROBNP+
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 “probnp”. A notice may cover another product or only some lots: read it to see what it covers.
- proBNP II Stat Calset, proBNP II Calset and Calset proBNP II (2019-08-22)September 20, 2019 · Medical devices · Medical devices · Type III
- proBNP II STAT Calset and proBNP II Calibrator (2018-06-14)June 29, 2018 · Medical devices · Medical devices · Type III
- Elecsys proBNP II and proBNP II Stat (2017-03-13)March 31, 2017 · Medical devices · Medical devices · Type II
- Cardiac Control ProBNP For Cobas H232 (2016-08-30)August 30, 2016 · 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.