ApprovalTrail

Medical device licence · 61044 · Class 3

FLOWPRA SCREENING TEST

Yes: licensed in Canada

Licence status Issued (active); first licensed November 27, 2002. It is in Health Canada’s list of active licences.
Licence number
61044
Licence holder
One Lambda IncWest Hills, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
November 27, 2002
Devices covered
17

Devices on this licence

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

  • FLOWPRA CLASS I AND II SCREENING TESTS
  • FLOWPRA CLASS I AND II SCREENING TESTS SAMPLE
  • FLOWPRA CLASS I SCREENING TEST
  • FLOWPRA CLASS I SCREENING TEST SAMPLE
  • FLOWPRA CLASS I SINGLE AG
  • FLOWPRA CLASS I SINGLE AG SUP GR10
  • FLOWPRA CLASS I SINGLE AG SUP GR5
  • FLOWPRA CLASS I SINGLE AG SUP GR6
  • FLOWPRA CLASS I SINGLE AG SUP GR7
  • FLOWPRA CLASS I SINGLE AG SUP GR8
  • FLOWPRA CLASS I SINGLE AG SUP GR9
  • FLOWPRA CLASS II SCREENING TEST
  • FLOWPRA CLASS II SCREENING TEST SAMPLE
  • FLOWPRA SPEC. CLASS 1/33 HLA ANTIBODY DETECTION TEST
  • FLOWPRA SPEC. CLASS 1/44 HLA ANTIBODY DETECTION TEST
  • FLOWPRA SPEC. CLASS I HLA ANTIBODY DETECTION TEST
  • FLOWPRA SPECIFIC CLASS II HLA ANTIBODY DETECTION TEST

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “flowpra”. A notice may cover another product or only some lots: read it to see what it covers.

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