ApprovalTrail

Medical device licence · 67831 · Class 2

PHADIA 250 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed March 29, 2005. It is in Health Canada’s list of active licences.
Licence number
67831
Licence holder
Phadia AbUppsala, Sweden
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
March 29, 2005
Devices covered
100

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • DILUTION PLATE, PHADIA 250
  • ELIA ANTI-TG WELL
  • ELIA ANTI-TPO WELL
  • 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 ANTI-TSH-R WELL
  • ELIA CALPROTECTIN 2 CURVE CONTROL STRIPS
  • ELIA DFS70 POSITIVE CONTROL 250
  • ELIA DFS70 WELL
  • ELIA GASTRIC POSITIVE CONTROL 250
  • ELIA IGM CONJUGATE 200
  • ELIA INTRINSIC FACTOR WELL
  • ELIA M2 POSITIVE CONTROL 250
  • ELIA M2 WELL
  • ELIA PARIETAL CELL WELL
  • ELIA RF IGG
  • ELIA SCL-70S WELL
  • ELIA SMDP-S WELL
  • ELIA SSNDA POSITIVE CONTROL 250
  • ELIA SYMPHONYS WELL
  • IMMUNOCAP SPECIFIC IGG
  • IMMUNOCAP TRYPTASE CONTROL
  • PHADIA 250 SYSTEM - ELIA SCI-70
  • PHADIA 250 SYSTEM - ELIA SSDNA WELL
  • PHADIA 250 SYSTEM - ALLERGENS ASSAY
  • PHADIA 250 SYSTEM - ELIA ANTI-IGA
  • PHADIA 250 SYSTEM - ELIA ANTI-IGA POSITIVE CONTROL 250
  • PHADIA 250 SYSTEM - ELIA ASCA IGA WELL
  • PHADIA 250 SYSTEM - ELIA ASCA IGG WELL
  • PHADIA 250 SYSTEM - ELIA ASCA POSITIVE CONTROL 250
  • PHADIA 250 SYSTEM - ELIA BETA2-GLYCOPROTEIN I IGA
  • PHADIA 250 SYSTEM - ELIA BETA2-GLYCOPROTEIN I IGG
  • PHADIA 250 SYSTEM - ELIA BETA2-GLYCOPROTEIN I IGM
  • PHADIA 250 SYSTEM - ELIA CALIBRATORS
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN CALIBRATOR STRIPS
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN CALIBRATOR WELL
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN CONJUGATE 200
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN CONJUGATE 50
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN CURVE CONTROL STRIPS
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN EXTRACTION BUFFER
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN NEGATIVE CONTROL 250
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN POSITIVE CONTROL 250
  • PHADIA 250 SYSTEM - ELIA CALPROTECTIN WELL
  • PHADIA 250 SYSTEM - ELIA CARDIOLIPIN IGA
  • PHADIA 250 SYSTEM - ELIA CARDIOLIPIN IGG ASSAY
  • PHADIA 250 SYSTEM - ELIA CARDIOLIPIN IGM ASSAY
  • PHADIA 250 SYSTEM - ELIA CCP ASSAY
  • PHADIA 250 SYSTEM - ELIA CCP IGA WELL
  • PHADIA 250 SYSTEM - ELIA CELIKEY IGA ASSAY
  • PHADIA 250 SYSTEM - ELIA CELIKEY IGG ASSAY
  • PHADIA 250 SYSTEM - ELIA CENP
  • PHADIA 250 SYSTEM - ELIA CONTROLS
  • PHADIA 250 SYSTEM - ELIA CTD SCREEN (FLOUROENZYMEIMMUNOASSAY FOR ANTI PR3)
  • PHADIA 250 SYSTEM - ELIA DSDNA
  • PHADIA 250 SYSTEM - ELIA FIBRILLARIN FLUOROENZYMEIMMUNOASSAY FOR ANTI FIBRILLARIN ANTIBODIES
  • PHADIA 250 SYSTEM - ELIA GBM
  • PHADIA 250 SYSTEM - ELIA GLIADIN DP IGA WELL
  • PHADIA 250 SYSTEM - ELIA GLIADIN DP IGG WELL
  • PHADIA 250 SYSTEM - ELIA IGA CALIBRATOR WELL
  • PHADIA 250 SYSTEM - ELIA JO-1
  • PHADIA 250 SYSTEM - ELIA LA
  • PHADIA 250 SYSTEM - ELIA MI-2 FLUOROENZYMEIMMUNOASSAY FOR ANTI MI-2 ANTIBODIES
  • PHADIA 250 SYSTEM - ELIA MPO S WELL
  • PHADIA 250 SYSTEM - ELIA PCNA WELL
  • PHADIA 250 SYSTEM - ELIA PM-SCL
  • PHADIA 250 SYSTEM - ELIA PR3 (FLOUROENZYMEIMMUNOASSAY FOR ANTI PR3 ANTI)
  • PHADIA 250 SYSTEM - ELIA RNP 70
  • PHADIA 250 SYSTEM - ELIA RO
  • PHADIA 250 SYSTEM - ELIA RO52 WELL
  • PHADIA 250 SYSTEM - ELIA RO60 WELL
  • PHADIA 250 SYSTEM - ELIA SM
  • PHADIA 250 SYSTEM - ELIA STOOL EXTRACTION KIT
  • PHADIA 250 SYSTEM - ELIA SYMPHONY
  • PHADIA 250 SYSTEM - ELIA THYROID POSITIVE CONTROL 250
  • PHADIA 250 SYSTEM - ELIA U1RNP
  • PHADIA 250 SYSTEM - IMMUNOCAP SPECIFIC IGG4 ASSAY
  • PHADIA 250 SYSTEM - INSTRUMENT
  • PHADIA 250 SYSTEM - INSTRUMENT REAGENTS
  • PHADIA 250 SYSTEM - PHADIATOP/PHADIATOP INFANT(INHALED ALLERGENS) ASSAY
  • PHADIA 250 SYSTEM - RF POSITIVE CONTROL 250
  • PHADIA 250 SYSTEM - SPECIFIC IGE ASSAY
  • PHADIA 250 SYSTEM - THYROID PEROXIDASE
  • PHADIA 250 SYSTEM - TOTAL IGE ASSAY
  • PHADIA 250 SYSTEM - TOTAL IGE LOW RANGE ASSAY
  • PHADIA 250 SYSTEM - TRYPTASE CONJUGATE ASSAY
  • PHADIA 250 SYSTEM- ELIA CALPROTECTIN 2 CALIBRATOR STRIPS
  • PHADIA 250 SYSTEM- ELIA CALPROTECTIN 2 CALIBRATOR WELL
  • PHADIA 250 SYSTEM- ELIA CALPROTECTIN 2 CONJUGATE 200
  • PHADIA 250 SYSTEM- ELIA CALPROTECTIN 2 CONJUGATE 50
  • PHADIA 250 SYSTEM- ELIA CALPROTECTIN 2 EXTRACTION BUFFER
  • PHADIA 250 SYSTEM- ELIA CALPROTECTIN 2 WELL
  • PHADIA 250 SYSTEM- ELIA RF IGA (FLOUROENZYMEIMMUNOASSAY F/RHEUMATIC FACTOR)
  • PHADIA 250 SYSTEM- ELIA RF IGM (FLOUROENZYMEIMMUNOASSAY F/RHEUMATIC FACTOR)
  • PHADIA 250 SYSTEM- ELIA RIB-P (FLOUROENZYMEIMMUNOASSAY F/ANTI RIB-P AB)
  • PHADIA 250 SYSTEM- ELIA RNA POL III WELL
  • PHADIA 250 SYSTEM- ELIA STOOL EXTRACTION KIT 2
  • PHADIA MAINTENANCE SOLUTION
  • PHADIA PRIME

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.