Device
The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx application for NextSeq 550Dx is used for sequencing run setup, run monitoring, primary and secondary analysis on the NextSeq...
Manufacturer
ILLUMINA, INC.
ILLUMINA, INC.
Model: 20074730
DI: 00816270020330
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx application for NextSeq 550Dx is used for sequencing run setup, run monitoring, primary and secondary analysis on the NextSeq 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay.
The software (SW) includes the UDI information in the User Interface.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
82ec9939-116f-4006-b71b-e4836f1ebff6
Distribution Status:
In Commercial Distribution
DUNS Number:
033305264
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00816270020330
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62173
Name: Nucleic acid sequencing reagent kit IVD
Definition:
A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.
FDA Product Codes
PFT
Reagents For Molecular Diagnostic Test Systems