AccessGUDID - DEVICE: MiSeqDx Instrument (00816270020002)

GUDID

Device Identifier (DI) Information

Brand Name: MiSeqDx Instrument
Version or Model: 15036706
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DX-410-1001
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61957	Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)	A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFF	High Throughput Dna Sequence Analyzer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN130011	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56bf0a34-1169-46e4-8e8f-0d091ab854fb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016