ApprovalTrail

Medical device licence · 17940 · Class 3

CHOLESTECH L.D.X. SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed April 25, 2000. It is in Health Canada’s list of active licences.
Licence number
17940
Licence holder
Alere San Diego, Inc.San Diego, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 25, 2000
Devices covered
6

Devices on this licence

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

  • CHOLESTECH LDX ANALYZER
  • CHOLESTECH LDX GLUCOSE TEST
  • CHOLESTECH LDX HDL CHOLESTEROL TEST
  • CHOLESTECH LDX OPTICS CHECK CASSETTE
  • CHOLESTECH LDX TOTAL CHOLESTEROL TEST
  • CHOLESTECH LDX TRIGLYCERIDES TEST

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