Medical device licence · 61043 · Class 3
LAMBDA ANTIGEN TRAY (LAT)
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
- 61043
- 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
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I & II - 40 WELL PANEL
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I & II - 88 WELL PANEL
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I & II - 88 WELL PANEL - SAMPLE
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I & II - SAMPLES
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I - 40 WELL PANEL - 1 TEST/TRAY
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I - 40 WELL PANEL - 2 TEST/TRAY
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I - SINGLE ANTIGEN - 1 TEST
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS I - SINGLE ANTIGEN - SAMPLE
- LAMBDA ANTIGEN TRAY ELISA HLA CLASS II - 40 WELL PANEL - 2 TESTS
- LAMBDA ANTIGEN TRAY MIXED ELISA CLASS I & II - SAMPLE
- LAMBDA ANTIGEN TRAY MIXED ELISA CLASS I - 100 TEST
- LAMBDA ANTIGEN TRAY MIXED ELISA HLA CLASS I & II - 10 TESTS/TRAY
- LAMBDA ANTIGEN TRAY MIXED ELISA HLA CLASS I & II - 20 TESTS/TRAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.