Medical device licence · 106871 · Class 2
ELIA TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106871
- Licence holder
- Phadia AbUppsala, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 25, 2021
- Devices covered
- 109
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELIA AIH POSITIVE CONTROL
- ELIA AIH POSITIVE CONTROL 2500/5000
- ELIA ANA POSITIVE CONTROL
- ELIA ANA POSITIVE CONTROL 2500/5000
- ELIA ANCA/GBM POSITIVE CONTROL
- ELIA ANCA/GBM POSITIVE CONTROL 2500/5000
- ELIA ANTI-IGA POSITIVE CONTROL
- ELIA ANTI-IGA WELL
- ELIA ANTI-TG WELL
- ELIA ANTI-TPO WELL
- ELIA ANTI-TSH-R
- ELIA ANTI-TSH-R CALIBRATOR STRIPS
- ELIA ANTI-TSH-R CONJUGATE
- ELIA ANTI-TSH-R CURVE CONTROL STRIPS
- ELIA ANTI-TSH-R SAMPLE DILUENT
- ELIA APS POSITIVE CONTROL
- ELIA APS POSITIVE CONTROL 2500/5000
- ELIA ASCA IGA WELL
- ELIA ASCA IGG WELL
- ELIA ASCA POSITIVE CONTROL
- ELIA ASCA POSITIVE CONTROL 2500/5000
- ELIA BETA2-GLYCOPROTEIN I IGA WELL
- ELIA BETA2-GLYCOPROTEIN I IGG WELL
- ELIA BETA2-GLYCOPROTEIN I IGM WELL
- ELIA CALPROTECTIN 2 CALIBRATOR STRIPS
- ELIA CALPROTECTIN 2 CALIBRATOR WELL
- ELIA CALPROTECTIN 2 CONJUGATE
- ELIA CALPROTECTIN 2 CURVE CONTROL STRIPS
- ELIA CALPROTECTIN 2 EXTRACTION BUFFER
- ELIA CALPROTECTIN 2 WELL
- ELIA CALPROTECTIN NEGATIVE CONTROL
- ELIA CALPROTECTIN NEGATIVE CONTROL 2500/5000
- ELIA CALPROTECTIN POSITIVE CONTROL
- ELIA CALPROTECTIN POSITIVE CONTROL 2500/5000
- ELIA CARDIOLIPIN IGA WELL
- ELIA CARDIOLIPIN IGG WELL
- ELIA CARDIOLIPIN IGM WELL
- ELIA CCP IGA WELL
- ELIA CCP POSITIVE CONTROL
- ELIA CCP POSITIVE CONTROL 2500/5000
- ELIA CCP WELL
- ELIA CELIAC POSITIVE CONTROL
- ELIA CELIAC POSITIVE CONTROL 2500/5000
- ELIA CELIKEY IGA WELL
- ELIA CELIKEY IGG WELL
- ELIA CENP WELL
- ELIA CTD SCREEN WELL
- ELIA DFS70 POSITIVE CONTROL
- ELIA DFS70 POSITIVE CONTROL 2500/5000
- ELIA DFS70 WELL
- ELIA DSDNA WELL
- ELIA FIBRILLARIN WELL
- ELIA GASTRIC POSITIVE CONTROL
- ELIA GASTRIC POSITIVE CONTROL 2500/5000
- ELIA GBM WELL
- ELIA GLIADINDP IGA WELL
- ELIA GLIADINDP IGG WELL
- ELIA IGA CALIBRATOR STRIPS
- ELIA IGA CALIBRATOR WELL
- ELIA IGA CONJUGATE
- ELIA IGA CURVE CONTROL STRIPS
- ELIA IGG / IGM / IGA NEGATIVE CONTROL 2500/5000
- ELIA IGG CALIBRATOR STRIPS
- ELIA IGG CALIBRATOR WELL
- ELIA IGG CONJUGATE
- ELIA IGG CURVE CONTROL STRIPS
- ELIA IGG/IGM/IGA NEGATIVE CONTROL
- ELIA IGM CALIBRATOR STRIPS
- ELIA IGM CALIBRATOR WELL
- ELIA IGM CONJUGATE
- ELIA IGM CURVE CONTROL STRIPS
- ELIA INTRINSIC FACTOR WELL
- ELIA JO-1 WELL
- ELIA LA WELL
- ELIA LKM-1 WELL
- ELIA M2 POSITIVE CONTROL
- ELIA M2 POSITIVE CONTROL 2500/5000
- ELIA M2 WELL
- ELIA MI-2 WELL
- ELIA MPOS WELL
- ELIA PARIETAL CELL WELL
- ELIA PCNA WELL
- ELIA PM-SCL WELL
- ELIA PR3S WELL
- ELIA RF IGA WELL
- ELIA RF IGG WELL
- ELIA RF IGM WELL
- ELIA RF POSITIVE CONTROL
- ELIA RF POSITIVE CONTROL 2500/5000
- ELIA RIB-P WELL
- ELIA RNA POL III WELL
- ELIA RNP70 WELL
- ELIA RO WELL
- ELIA RO52 WELL
- ELIA RO60 WELL
- ELIA SAMPLE DILUENT
- ELIA SCL-70S WELL
- ELIA SMDP WELL
- ELIA SMDP-S WELL
- ELIA SSDNA POSITIVE CONTROL 250
- ELIA SSDNA POSITIVE CONTROL 2500/5000
- ELIA SSDNA WELL
- ELIA STOOL EXTRACTION BUFFER PLUS
- ELIA STOOL EXTRACTION KIT 2
- ELIA STOOL EXTRACTION KIT PLUS
- ELIA SYMPHONYS WELL
- ELIA THYROID POSITIVE CONTROL
- ELIA THYROID POSITIVE CONTROL 2500/5000
- ELIA U1RNP WELL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.