MiSeq™Dx Reagent Kit v3 Micro - The MiSeq™Dx Reagent Kit v3 Micro uses libraries - ILLUMINA, INC.

Duns Number:033305264

Device Description: The MiSeq™Dx Reagent Kit v3 Micro uses libraries prepared from DNA where sample indexes an 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

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More Product Details

Catalog Number

20063860

Brand Name

MiSeq™Dx Reagent Kit v3 Micro

Version/Model Number

20063860

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PFT

Product Code Name

Reagents For Molecular Diagnostic Test Systems

Device Record Status

Public Device Record Key

b8cd374f-8d8e-4d31-9e1a-3f4b7eb39219

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ILLUMINA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 7
3 A medical device with high risk that requires premarket approval 1