Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx 20063024

GUDID 00816270020415

The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, and primary analysis on the NextSeq™ 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface.

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD
Primary Device ID00816270020415
NIH Device Record Key032e9610-c18e-4768-8b9d-c0f2ab708b75
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocal Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx
Version Model Number20063024
Catalog Number20063024
Company DUNS033305264
Company NameILLUMINA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-809-4566
Emailtechsupport@illumina.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816270020415 [Primary]

FDA Product Code

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 Date2022-11-15
Device Publish Date2022-11-07

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