| Primary Device ID | 00816270020378 |
| NIH Device Record Key | 610932b9-9bce-431c-a311-da7d2922bbd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Local Run Manager CF 139-Variant 2.0 Micro Analysis Module |
| Version Model Number | 20072975 |
| Catalog Number | 20072975 |
| Company DUNS | 033305264 |
| Company Name | ILLUMINA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816270020378 [Primary] |
| PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-13 |
| Device Publish Date | 2023-06-15 |
| 00816270020217 - TruSight™ Oncology Comprehensive | 2024-12-17 The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic t |
| 00816270020644 - TruSight™ Oncology RNA Control | 2024-12-17 The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality |
| 00816270020651 - TruSight™ Oncology DNA Control IVD | 2024-12-17 The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality |
| 00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module | 2023-07-13 The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencin |
| 00816270020286 - Local Run Manager CF 139 Variant Analysis Module | 2023-07-13 The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The ass |
| 00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module | 2023-07-13The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis. |
| 00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module | 2023-07-13 The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when p |
| 00816270020385 - Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module | 2023-07-13 The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Ass |
| 00816270020392 - Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx | 2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri |