Medical device licence · 92256 · Class 3
STAT PROFILE PRIME CCS ANALYZER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 4, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92256
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 4, 2013
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALIBRATOR CARTRIDGE CCS COMP 400 SAMPLE
- KIT CLOT CATCHER CAPILLARY
- KIT CLOT CATCHER SYRINGE
- LINEARITY STANDARD SET A LEVELS 1 2 3 4
- NOVA LINEARITY LEVEL 1,2,3,4
- PRIME ACC PACK
- PRIME AMPULED CONTROL ABG/CCS
- PRIME AUTO QC CARTRIDGE 200 SAMPLE
- PRIME AUTO QC CARTRIDGE CCS 100 SAMPLE
- PRIME AUTO QC CARTRIDGE CCS 300 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS 100 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS 200 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS 300 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS 400 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS 500 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS COMP 100 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS COMP 200 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS COMP 300 SAMPLE
- PRIME CALIBRATOR CARTRIDGE CCS COMP 500 SAMPLE
- PRIME CCS COMP W/SCANNER
- PRIME CCS COMP W/SCANNER REMANUFACTURED
- PRIME PROBE S LINE
- PRIME PROBE S LINE 100 (MU)L
- PRIME REFERENCE CARTRIDGE
- PRIME SAFETY SAMPLE PORT 5 PK
- PRIME SCANNER
- PRIME SENSOR CARD CCS COMP
- PRIME SENSOR CARD CCS COMP 100
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.