ApprovalTrail

Medical device licence · 61426 · Class 2

BINAXNOW MALARIA

Yes: licensed in Canada

Licence status Issued (active); first licensed January 8, 2003. It is in Health Canada’s list of active licences.
Licence number
61426
Licence holder
Abbott Diagnostics Scarborough, Inc.Scarborough, ME, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
January 8, 2003
Devices covered
1

Devices on this licence

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

  • BINAXNOW MALARIA

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