Medical device licence · 94170 · Class 3
STAT PROFILE PRIME ABG ANALYZER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 5, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94170
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 5, 2014
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRIME ABG ANALYZER SYSTEM
- PRIME AMPULED CONTROL ABG/CCS
- PRIME AUTO QC CARTRIDGE ABG
- PRIME AUTO QC CARTRIDGE ABG 100 SAMPLE
- PRIME AUTO QC CARTRIDGE ABG 200 SAMPLE
- PRIME AUTO QC CARTRIDGE ABG 300 SAMPLE
- PRIME CALIBRATOR CARTRIDGE ABG 100 SAMPLE
- PRIME CALIBRATOR CARTRIDGE ABG 200 SAMPLE
- PRIME CALIBRATOR CARTRIDGE ABG 300 SAMPLE
- PRIME CALIBRATOR CARTRIDGE ABG 400 SAMPLE
- PRIME CALIBRATOR CARTRIDGE ABG 500 SAMPLE
- PRIME CALIBRATOR CARTRIDGE ABG 600 SAMPLE
- PRIME SENSOR CARD ABG
- REMANUFACTURED PRIME ABG ANALYZER SYSTEM
- REMANUFACTURED PRIME ABG W/ SCANNER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.