Medical device licence · 71115 · Class 2
SPECIMEN/TRANSPORTATION DEVICES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71115
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 18, 2006
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS PCR MEDIA DUAL SWAB SAMPLE KIT
- COBAS PCR MEDIA UNI SWAB SAMPLE KIT
- COBAS VIVODX MRSA COLLECTION AND TRANSPORT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.