Medical device licence · 99189 · Class 3
COBAS LIAT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 18, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99189
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 18, 2017
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS CDIFF NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM
- COBAS CDIFF POSITIVE AND NEGATIVE CONTROL KIT FOR USE ON THE COBAS LIAT SYSTEM
- COBAS INFLUENZA A/B & RSV
- COBAS INFLUENZA A/B & RSV QUALITY CONTROL KIT
- COBAS LIAT ANALYZER
- COBAS LIAT CDIFF SCRIPT
- COBAS LIAT CT, NG AND MG CONTROL KIT
- COBAS LIAT CT/NG
- COBAS LIAT CT/NG SCRIPT
- COBAS LIAT CT/NG/MG
- COBAS LIAT CT/NG/MG SCRIPT
- COBAS LIAT INFLUENZA A-B&RSV-SCRIPT
- COBAS LIAT INFLUENZA A/B & RSV SCRIPT
- COBAS LIAT SOFTWARE V 3.2 UPDATE KEY
- COBAS LIAT SOFTWARE V 3.3 UPDATE KEY
- COBAS LIAT STREP A SCRIPT
- COBAS STREP A NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM
- COBAS STREP A QUALITY CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.