5200 Illumina Way, San Diego, United States, CA 92122
Showing 1–20 of 70 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| DRAGEN® for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| DRAGEN for Illumina Prep with Enrichment Dx for NextSeq 550Dx | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| DRAGEN® for Illumina™ Prep with Enrichment Dx for NovaSeq 6000Dx | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| ILLUMINA BEADXPRESS SYSTEM | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Illumina Connected Run TruSight™ Oncology Comprehensive HRD (EU, DRAGEN) Analysis Module | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Illumina DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 Samples) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Illumina DRAGEN Server for NextSeq 550Dx | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Illumina DRAGEN® Server for NextSeq550Dx | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ILLUMINA MISEQDX PLATFORM | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| iScan™Dx | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| iScanDx | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| llumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
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