ApprovalTrail

Medical device licence · 62606 · Class 4

IMMULITE 1000 SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed May 28, 2003; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
62606
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class IV (highest risk)
Licence type
System
First licensed
May 28, 2003
Ended
December 9, 2025
Devices covered
8

Devices on this licence

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

  • IMMULITE 1000 SYSTEM - ANALYZER - CLASS IV
  • IMMULITE 1000 SYSTEM - ANTI-HBC ASSAY
  • IMMULITE 1000 SYSTEM - ANTI-HBC ASSAY
  • IMMULITE 1000 SYSTEM - ANTI-HBS ASSAY
  • IMMULITE 1000 SYSTEM - ANTI-HBS ASSAY
  • IMMULITE 1000 SYSTEM - CHEMILUMINESCENT SUBSTRATE
  • IMMULITE 1000 SYSTEM - HBSAG ASSAY
  • IMMULITE 1000 SYSTEM - HBSAG CONFIRMATORY ASSAY

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