AccessGUDID - DEVICE: PGDx elio™ tissue complete (00192721000770)

GUDID

Device Identifier (DI) Information

Brand Name: PGDx elio™ tissue complete
Version or Model: B01103200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B01103200
Company Name: PERSONAL GENOME DIAGNOSTICS INC.

Primary DI Number: 00192721000770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963427120 *Terms of Use

Device Description: PGDx elio™ tissue complete software

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:	No
Prescription Use (Rx):	No
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
PZM	Next Generation Sequencing Based Tumor Profiling Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192063	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba8aa3c2-0086-4574-bad8-e8559811c7a4
Public Version Date: August 07, 2024
Public Version Number: 3
DI Record Publish Date: May 11, 2020