Medical device licence · 93350 · Class 2
PENTRA C200
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed May 30, 2014; ended October 9, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 93350
- Licence holder
- Horiba Abx SasMontpellier, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 30, 2014
- Ended
- October 9, 2020
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABX PENTRA 400 CLINIAL CHEMISTRY SYSTEM - INSTRUMENT W/OUT ISE MODULE
- ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - QUALITEST SOLUTION
- ABX PENTRA CALCIUM AS CP
- ABX PENTRA ENZYMATIC CREATININE CP
- ABX PENTRA FERRITIN 2
- ABX PENTRA HDL DIRECT 100 CP
- ABX PENTRA IGA CP
- ABX PENTRA IGG CP
- ABX PENTRA IGM CP
- ABX PENTRA ISE CLEANER CP
- ABX PENTRA SP CAL
- ABX PENTRA SP CONTROL
- ABX PENTRA TRANSFERRIN ASSAY
- ABX PENTRA TRANSFERRIN CP
- PENTRA C200
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “pentra”. A notice may cover another product or only some lots: read it to see what it covers.
- ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM (2016-02-19)May 31, 2016 · Medical devices · Medical devices · Type II
- ABX Pentra 400 (2016-01-18)February 12, 2016 · Medical devices · Medical devices · Type III
- ABX Pentra 400 Clinical Chemistry Systems (2014-09-26)November 26, 2014 · Medical devices · Medical devices · Type III
- ABX PENTRA Magnesium RTU (2014-09-26)October 10, 2014 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.