AccessGUDID - DEVICE: MiSeqDx Reagent Kit v3 (00816270020071)

GUDID

Device Identifier (DI) Information

Brand Name: MiSeqDx Reagent Kit v3
Version or Model: 20012552
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20012552
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020071
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: The MiSeqDx Reagent Kit v3 uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Illumina MiSeqDx Reagent Kit v3 is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeqDx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The MiSeqDx Reagent Kit v3 is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20011196, MiSeqDx Reagent Kit v3, 1/2; 20011197, iSeqDx Reagent Kit v3, 2/2

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62173	Nucleic acid sequencing reagent kit IVD	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents For Molecular Diagnostic Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 24b0b061-7263-4cdf-80ae-8785b2013b72
Public Version Date: January 10, 2022
Public Version Number: 4
DI Record Publish Date: February 06, 2018