Medical device licence · 12976 · Class 2
MDA SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed October 8, 1999; ended October 31, 2007. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 12976
- Licence holder
- Biomerieux SaRockland, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 8, 1999
- Ended
- October 31, 2007
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HEPARIN ANTI-X-A ASSAY
- MDA ALPHA-2-ANTIPLASMIN
- MDA ANTITHROMBIN III
- MDA D-DIMER
- MDA FIBRIQUIK
- MDA IX DEFICIENT PLASMA
- MDA PLASMINOGEN
- MDA PROTEIN C
- MDA REFERENCE PLASMA
- MDA THROMBOQUIK
- MDA V DEFICIENT PLASMA
- MDA VERICAL CALIBRATOR SET
- MDA VII DEFICIENT PLASMA
- MDA VIII DEFICIENT PLASMA
- MDA X DEFICIENT PLASMA
- MDA XI DEFICIENT PLASMA
- MDA XII DEFICIENT PLASMA
- MDA-180 INSTRUMENT - CLASS II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.