FDA Device Establishments · JSON-LD · Markdown
FEI 3003218906 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3003218906 |
|---|---|
| Owner / Operator | Illumina, Inc. (#10030352) |
| Address | 5200 Illumina Way, San Diego, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PFT |
| Regulation § (21 CFR) | 862.3800 |
| Proprietary names | DRAGEN for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx; Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx; NovaSeq 6000Dx Library Tube; NovaSeq 6000Dx Library Tube, 24 pack; Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples); TruSeq Custom Amplicon Kit Dx- FFPE; MiSeqDx Reagent Kit V3; NovaSeq 6000Dx S4 Reagent v1.5 Kit (300 cycles); NovaSeq 6000Dx S4 Buffer Cartridge; NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles) |
Source: openFDA. Public-domain (CC0).