TruSeq Custom Amplicon Kit Dx - FFPE QC - DNA from peripheral whole blood specimens and - ILLUMINA, INC.

Duns Number:033305264

Device Description: DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tis DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.

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More Product Details

Catalog Number

20006259

Brand Name

TruSeq Custom Amplicon Kit Dx - FFPE QC

Version/Model Number

20006259

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

21c7b619-eb5c-4ba4-ab78-d3f09158e27e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 09, 2018

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