Primary Device ID | 00816270020149 |
NIH Device Record Key | 5234fc51-bcdc-41f4-ba5b-ca8f217e255a |
Commercial Distribution Discontinuation | 2020-04-09 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | TruSight™ Cystic Fibrosis Library Preparation |
Version Model Number | 20036925 |
Catalog Number | 20036925 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816270020149 [Primary] |
PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection |
PFT | Reagents For Molecular Diagnostic Test Systems |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-17 |
Device Publish Date | 2020-04-09 |
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 | 2023-07-13 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRUSIGHT 88730128 not registered Live/Pending |
Illumina Inc. 2019-12-17 |
TRUSIGHT 88067404 not registered Live/Pending |
Olympus Corporation 2018-08-06 |
TRUSIGHT 87659557 5531932 Live/Registered |
TRUSIGHT SOLUTIONS LLC 2017-10-25 |
TRUSIGHT 87619161 5531824 Live/Registered |
TRUSIGHT SOLUTIONS LLC 2017-09-22 |
TRUSIGHT 87586785 not registered Live/Pending |
Bausch & Lomb Incorporated 2017-08-28 |
TRUSIGHT 86380456 not registered Dead/Abandoned |
Trusight Inc. 2014-08-28 |
TRUSIGHT 86074775 4498222 Live/Registered |
Illumina, Inc. 2013-09-25 |
TRUSIGHT 85153024 4172327 Dead/Cancelled |
MRA-THE MANAGEMENT ASSOCIATION, INC. 2010-10-14 |
TRUSIGHT 85146650 4139839 Dead/Cancelled |
MRA-THE MANAGEMENT ASSOCIATION, INC. 2010-10-06 |
TRUSIGHT 77570947 3886853 Live/Registered |
Modern Medical, Inc. 2008-09-16 |
TRUSIGHT 73674893 1504638 Dead/Cancelled |
TRUSIGHT CORPORATION 1987-07-27 |