TruSight™ Cystic Fibrosis Library Preparation

Basic Information

• Brand Name: TruSight™ Cystic Fibrosis Library Preparation
• Primary DI: 00816270020149
• Version / Model: 20036925
• Catalog Number: 20036925
• Company Name: ILLUMINA, INC.
• Labeler DUNS: 033305264
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-09
• Public Version: 2
• Public Version Date: 2023-07-11
• Public Version Status: Update
• Public Device Record Key: 5234fc51-bcdc-41f4-ba5b-ca8f217e255a
• Distribution End Date: 2020-04-09

Device Description

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 consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035693, TruSight™ Cystic Fibrosis Library Prep, 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep, 3/3.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFT	Reagents For Molecular Diagnostic Test Systems	Clinical Chemistry	862.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62604	Nucleic acid library construction kit IVD	A collection of reagents and other associated materials intended to be used for the construction of fragmented nucleic acids [deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for use in genomic sequencing assays. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs) and is intended to be used for whole genome and/or complementary deoxyribonucleic acid (cDNA) library construction.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816270020149	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius