Praxis Extended RAS Panel - The Praxis™ Extended RAS Panel assay is designed - ILLUMINA, INC.

Duns Number:033305264

Device Description: The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 muta The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run.Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.

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More Product Details

Catalog Number

20012431

Brand Name

Praxis Extended RAS Panel

Version/Model Number

20012431

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

P160038

Product Code Details

Product Code

PQP

Product Code Name

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Device Record Status

Public Device Record Key

790a0fb3-37e6-452f-a894-9024d509d34e

Public Version Date

June 03, 2022

Public Version Number

4

DI Record Publish Date

August 28, 2017

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