ApprovalTrail

Medical device licence · 1076 · Class 3

IMMULITE SYSTEM (DPC-LA)

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed February 5, 1999; ended October 31, 2011. It is in Health Canada’s archive of licences no longer in force.
Licence number
1076
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 5, 1999
Ended
October 31, 2011
Devices covered
21

Devices on this licence

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

  • IMMULITE SYSTEM - ALPHA FETOPROTIEN (AFP) ASSAY
  • IMMULITE SYSTEM - CARDIAC CONTROL MODULE
  • IMMULITE SYSTEM - CEA ASSAY
  • IMMULITE SYSTEM - CHEMILUMINESCENT IMMUNOASSAY ANALYZER CLASS 3
  • IMMULITE SYSTEM - CK-MB ASSAY
  • IMMULITE SYSTEM - CMV IGG ASSAY
  • IMMULITE SYSTEM - FREE PSA ASSAY
  • IMMULITE SYSTEM - HERPES I & II IGG ASSAY
  • IMMULITE SYSTEM - HERPES I & II IGM ASSAY
  • IMMULITE SYSTEM - MYOGLOBIN ASSAY
  • IMMULITE SYSTEM - PSA ASSAY
  • IMMULITE SYSTEM - RUBELLA IGG ASSAY
  • IMMULITE SYSTEM - RUBELLA IGG QUANTITATIVE ASSAY
  • IMMULITE SYSTEM - RUBELLA QUALITATIVE IGM ASSAY
  • IMMULITE SYSTEM - THIRD GENERATION PSA ASSAY
  • IMMULITE SYSTEM - TOXOPLASMA IGM ASSAY
  • IMMULITE SYSTEM - TOXOPLASMA QUANTITATIVE IGG ASSAY
  • IMMULITE SYSTEM - TROPONIN I ASSAY
  • IMMULITE SYSTEM - TURBO CK-MB ASSAY
  • IMMULITE SYSTEM - TURBO MYOGLOBIN ASSAY
  • IMMULITE SYSTEM - TURBO TROPONIN I ASSAY

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