ApprovalTrail

Medical device licence · 34369 · Class 2

FIBRINOGEN ASSAY KIT

Yes: licensed in Canada

Licence status Issued (active); first licensed November 28, 2001. It is in Health Canada’s list of active licences.
Licence number
34369
Licence holder
Helena Laboratories, CorpBeaumont, TX, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
November 28, 2001
Devices covered
1

Devices on this licence

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

  • FIBRINOGEN ASSAY KIT

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