Medical device licence · 108388 · Class 4
COBAS X800 SYSTEM
Yes: licensed in Canada
Licence status Issued with conditions; first licensed October 12, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108388
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 12, 2022
- Devices covered
- 52
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 5800
- COBAS 5800 INSTRUMENT SW
- COBAS 6800
- COBAS 6800 INSTRUMENT SOFTWARE
- COBAS 8800
- COBAS 8800 INSTRUMENT SOFTWARE
- COBAS OMNI LYSIS REAGENT
- COBAS OMNI MGP REAGENT
- COBAS OMNI SPECIMEN DILUENT
- COBAS OMNI WASH REAGENT
- KIT UPDATE HW 6800 2ND ANALYTIC UNIT
- KIT UPGRADE HW C6800 FOR SW2.0
- KIT UPGRADE HW C8800 FOR SW2.0
- SW COBAS 5800 BKV ASAP
- SW COBAS 5800 CMV ASAP
- SW COBAS 5800 CT/NG ASAP
- SW COBAS 5800 DPX ASAP
- SW COBAS 5800 EBV ASAP
- SW COBAS 5800 HBV ASAP
- SW COBAS 5800 HBV ASAP SOFTWARE VERSION 1.2
- SW COBAS 5800 HCV ASAP SOFTWARE VERSION 1.1
- SW COBAS 5800 HIV-1 ASAP SOFTWARE VERSION 1.2
- SW COBAS 5800 HIV-1/2QUAL-SERUM/PLASMA ASAP SOFTWARE VERSION 1.1
- SW COBAS 5800 HIV-1/2QUAL-SERUM/PLASMA ASAP SOFTWARE VERSION 1.2
- SW COBAS 5800 HPV-GT ASAP
- SW COBAS 5800 HPV-HR ASAP
- SW COBAS 5800 MPX ASAP
- SW COBAS 5800 MPX ASAP SOFTWARE VERSION 1.2
- SW COBAS 5800 RESP-FLEX ASAP V1.3
- SW COBAS 5800 TV-MG ASAP
- SW COBAS 5800 WNV ASAP
- SW COBAS X800 BABESIA
- SW COBAS X800 BKV
- SW COBAS X800 CMV
- SW COBAS X800 CT/NG
- SW COBAS X800 DPX
- SW COBAS X800 EBV
- SW COBAS X800 HBV
- SW COBAS X800 HCV
- SW COBAS X800 HIV-1
- SW COBAS X800 HIV-1/2 QUAL PLA/SER
- SW COBAS X800 HPV-GT
- SW COBAS X800 HPV-HR
- SW COBAS X800 MALARIA
- SW COBAS X800 MPX
- SW COBAS X800 RESP-FLEX
- SW COBAS X800 RESP-FLEX ASAP V1.3
- SW COBAS X800 SCOV2-FLUA/B
- SW COBAS X800 SCOV2-QL
- SW COBAS X800 TV/MG
- SW COBAS X800 WNV
- X800 DATA MANAGER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.