Medical device licence · 102861 · Class 3
NEXTSEQ 550DX
Yes: licensed in Canada
Licence status Issued (active); first licensed May 17, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102861
- Licence holder
- Illumina, Inc.San Diego, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 17, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEXTSEQ 550DX ACCESSORY BOX (300 CYCLES)
- NEXTSEQ 550DX HIGH OUTPUT REAGENT KIT V2.5 (300 CYCLES)
- NEXTSEQ 550DX HIGH OUTPUT REAGENT KIT V2.5 (75 CYCLES)
- NEXTSEQ 550DX INSTRUMENT
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 “nextseq”. A notice may cover another product or only some lots: read it to see what it covers.
- NextSeq™ 550Dx and MiSeq™Dx InstrumentsJuly 5, 2024 · Gastroenterology and urology - Chemistry · Performance · Type II
- NextSeq™ 550Dx and MiSeq™Dx InstrumentsMay 31, 2023 · Chemistry - Gastroenterology and urology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.