ApprovalTrail

Medical device licence · 884 · Class 3

IMMULITE 2000 SYSTEM (DPC-LA)

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed February 23, 1999; ended October 31, 2011. It is in Health Canada’s archive of licences no longer in force.
Licence number
884
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 23, 1999
Ended
October 31, 2011
Devices covered
19

Devices on this licence

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

  • IMMULITE 2000 - CEA ASSAY
  • IMMULITE 2000 SYSTEM - ALPHA FETO PROTEIN (AFP) ASSAY
  • IMMULITE 2000 SYSTEM - ANALYZER CLASS 3
  • IMMULITE 2000 SYSTEM - CHEMILUMINESCENT SUBSTRATE MODULE
  • IMMULITE 2000 SYSTEM - CHEMILUMINESCENT SUBSTRATE MODULE
  • IMMULITE 2000 SYSTEM - CK-MB ASSAY
  • IMMULITE 2000 SYSTEM - FREE BETA HCG ASSAY
  • IMMULITE 2000 SYSTEM - FREE PSA ASSAY
  • IMMULITE 2000 SYSTEM - MULTI-DILUENT
  • IMMULITE 2000 SYSTEM - MULTI-DILUENT
  • IMMULITE 2000 SYSTEM - MYOGLOBIN ASSAY
  • IMMULITE 2000 SYSTEM - NT-PROBNP ASSAY
  • IMMULITE 2000 SYSTEM - PSA ASSAY
  • IMMULITE 2000 SYSTEM - RUBELLA IGM ASSAY
  • IMMULITE 2000 SYSTEM - RUBELLA QUANTITATIVE IGG ASSAY
  • IMMULITE 2000 SYSTEM - THIRD GENERATION PSA ASSAY
  • IMMULITE 2000 SYSTEM - TOXOPLASMA IGG ASSAY
  • IMMULITE 2000 SYSTEM - TOXOPLASMA IGM ASSAY
  • IMMULITE 2000 SYSTEM - TROPONIN I ASSAY

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