ApprovalTrail

Medical device licence · 83549 · Class 3

QUIKCOAG PT-HS

Yes: licensed in Canada

Licence status Issued (active); first licensed August 5, 2010. It is in Health Canada’s list of active licences.
Licence number
83549
Licence holder
Biomedica Diagnostics Inc.Stamford, CT, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
August 5, 2010
Devices covered
1

Devices on this licence

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

  • QUIKCOAG PT WITH CALCIUM REAGENT

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