Medical device licence · 95113 · Class 2
PULSE ELITE AUTO NEPHELOMETER ANALYZER SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed May 7, 2015; ended October 24, 2016. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 95113
- Licence holder
- Pulse Scientific Inc.Burlington, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 7, 2015
- Ended
- October 24, 2016
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI-STREPTOLYSIN O (ASO) (NEPHELOMETRIC TEST)
- C-REACTIVE PROTEIN (CRP) (NEPHELOMETRIC TEST)
- HEMOGLOBIN A1C (HBA1C) (NEPHELOMETRIC TEST)
- MICROALBUMINURIC (MALB) (NEPHELOMETRIC TEST)
- NEUTROPHIL GELATINASE-ASSOCIATED LIPOCALIN (NGAL) (NEPHELOMETRIC TEST)
- PROCALCITONIN (PCT) (NEPHELOMETRIC TEST)
- PULSE ELITE AUTO NEPHELOMETER
- RHEUMATOID FACTOR (RF) (NEPHELOMETRIC TEST)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.