TruSight™ Cystic Fibrosis Library Preparation 20036925

GUDID 00816270020149

The TruSight Cystic Fibrosis Library Prep™ is a library preparation kit that supports the TruSight Cystic Fibrosis 139-Variant Assay™ and the TruSight Cystic Fibrosis Clinical Sequencing Assay™. The TruSight Cystic Fibrosis Library Preparation is an IVD kit constisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035691, TruSight™ Cystic Fibrosis Library Prep 1A; 20035692, TruSight™ Cystic Fibrosis Library Prep 1B; 20035693, TruSight™ Cystic Fibrosis Library Prep 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep 3/3; 20035695, TruSight™ Cystic Fibrosis Library Prep 3A; 20035696, TruSight™ Cystic Fibrosis Library Prep 3B.

ILLUMINA, INC.

Cystic fibrosis IVD, kit, multiplex
Primary Device ID00816270020149
NIH Device Record Key5234fc51-bcdc-41f4-ba5b-ca8f217e255a
Commercial Distribution Discontinuation2020-04-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTruSight™ Cystic Fibrosis Library Preparation
Version Model Number20036925
Catalog Number20036925
Company DUNS033305264
Company NameILLUMINA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816270020149 [Primary]

FDA Product Code

PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
PFTReagents For Molecular Diagnostic Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-17
Device Publish Date2020-04-09

Devices Manufactured by ILLUMINA, INC.

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 Control2024-12-17 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 IVD2024-12-17 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 Module2023-07-13 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 Module2023-07-13 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 Module2023-07-13 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 Module2023-07-13 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™Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri

Trademark Results [TruSight]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUSIGHT
TRUSIGHT
88730128 not registered Live/Pending
Illumina Inc.
2019-12-17
TRUSIGHT
TRUSIGHT
88067404 not registered Live/Pending
Olympus Corporation
2018-08-06
TRUSIGHT
TRUSIGHT
87659557 5531932 Live/Registered
TRUSIGHT SOLUTIONS LLC
2017-10-25
TRUSIGHT
TRUSIGHT
87619161 5531824 Live/Registered
TRUSIGHT SOLUTIONS LLC
2017-09-22
TRUSIGHT
TRUSIGHT
87586785 not registered Live/Pending
Bausch & Lomb Incorporated
2017-08-28
TRUSIGHT
TRUSIGHT
86380456 not registered Dead/Abandoned
Trusight Inc.
2014-08-28
TRUSIGHT
TRUSIGHT
86074775 4498222 Live/Registered
Illumina, Inc.
2013-09-25
TRUSIGHT
TRUSIGHT
85153024 4172327 Dead/Cancelled
MRA-THE MANAGEMENT ASSOCIATION, INC.
2010-10-14
TRUSIGHT
TRUSIGHT
85146650 4139839 Dead/Cancelled
MRA-THE MANAGEMENT ASSOCIATION, INC.
2010-10-06
TRUSIGHT
TRUSIGHT
77570947 3886853 Live/Registered
Modern Medical, Inc.
2008-09-16
TRUSIGHT
TRUSIGHT
73674893 1504638 Dead/Cancelled
TRUSIGHT CORPORATION
1987-07-27

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