Medical device licence · 85823 · Class 3
SECORE HLA SEQUENCED BASED TYPING KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85823
- Licence holder
- One Lambda IncWest Hills, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- April 18, 2011
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SECORE A LOCUS SEQUENCING KIT
- SECORE B LOCUS SEQUENCING KIT
- SECORE B LOCUS SEQUENCING KIT - SINGLE AMPLIFICATION SYSTEM
- SECORE CW LOCUS SEQUENCING KIT
- SECORE DPB1 LOCUS SEQUENCING KIT
- SECORE DQB1 TWO AMP SEQUENCING KIT
- SECORE DRB GROUP SEQUENCING KIT
- SECORE DRB1 LOCUS EXON 2 & 3 SEQUENCING KIT
- SECORE GSSP KITS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.