AccessGUDID - DEVICE: Praxis Extended RAS Panel (00816270020088)

GUDID

Device Identifier (DI) Information

Brand Name: Praxis Extended RAS Panel
Version or Model: 20012431
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20012431
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020088
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: 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.

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?
60943	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQP	Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 790a0fb3-37e6-452f-a894-9024d509d34e
Public Version Date: December 12, 2024
Public Version Number: 6
DI Record Publish Date: August 28, 2017