ApprovalTrail

Medical device licence · 67645 · Class 3

IMMULITE 2500 SYSTEM (DPC-UK)

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed March 3, 2005; ended November 1, 2013. It is in Health Canada’s archive of licences no longer in force.
Licence number
67645
Licence holder
Siemens Healthcare Diagnostics Products GmbhMarburg, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 3, 2005
Ended
November 1, 2013
Devices covered
18

Devices on this licence

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

  • IMMULITE 2500 SYSTEM - AFP ASSAY
  • IMMULITE 2500 SYSTEM - CARDIAC MARKER CONTROLS
  • IMMULITE 2500 SYSTEM - CEA ASSAY
  • IMMULITE 2500 SYSTEM - CK-MB ASSAY
  • IMMULITE 2500 SYSTEM - FREE BETA HCG ASSAY
  • IMMULITE 2500 SYSTEM - FREE PSA ASSAY
  • IMMULITE 2500 SYSTEM - FREE PSA ASSAY
  • IMMULITE 2500 SYSTEM - MULTI-DILUENTS
  • IMMULITE 2500 SYSTEM - MYOGLOBIN ASSAY
  • IMMULITE 2500 SYSTEM - NT-PROBNP ASSAY
  • IMMULITE 2500 SYSTEM - PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY
  • IMMULITE 2500 SYSTEM - RUBELLA IGM ASSAY
  • IMMULITE 2500 SYSTEM - RUBELLA QUANTITATIVE IGG ASSAY
  • IMMULITE 2500 SYSTEM - STAT TROPONIN I ASSAY
  • IMMULITE 2500 SYSTEM - SYSTEM REAGENTS
  • IMMULITE 2500 SYSTEM - THIRD GENERATION PSA ASSAY
  • IMMULITE 2500 SYSTEM - TOXOPLASMA QUANTITATIVE IGG ASSAY
  • IMMULITE 2500 SYSTEM - TUMOR MARKER CONTROLS

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