MiSeq™Dx Reagent Kit v3 Micro 20063860

GUDID 00816270020668

The MiSeq™Dx Reagent Kit v3 Micro 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 MiSeq™ Dx Reagent Kit v3 Micro is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeq™Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The MiSeq™Dx Reagent Kit v3 Micro is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20064640, MiSeqDx Reagent Kit v3 Micro, 1/2; 20064641, MiSeqDx Reagent Kit v3 Micro, 2/2

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD
Primary Device ID00816270020668
NIH Device Record Keyb8cd374f-8d8e-4d31-9e1a-3f4b7eb39219
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiSeq™Dx Reagent Kit v3 Micro
Version Model Number20063860
Catalog Number20063860
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816270020668 [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 Date2022-05-30
Device Publish Date2022-05-20

Devices Manufactured by ILLUMINA, INC.

00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module2023-07-13 The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencin
00816270020286 - Local Run Manager CF 139 Variant Analysis Module2023-07-13 The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The ass
00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module2023-07-13 The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when p
00816270020385 - Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module2023-07-13 The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Ass
00816270020392 - Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri
00816270020415 - Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, a
00816270020743 - DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx2022-11-15 The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, ru
00816270020453 - Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)2022-10-28 The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from periph

Trademark Results [MiSeq]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MISEQ
MISEQ
88491251 not registered Live/Pending
Illumina Inc.
2019-06-27
MISEQ
MISEQ
77840648 4042598 Live/Registered
Illumina, Inc.
2009-10-02

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