AccessGUDID - DEVICE: oncoReveal CDx (00860001218251)

GUDID

Device Identifier (DI) Information

Brand Name: oncoReveal CDx
Version or Model: HDA-LC-2001-48-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HDA-LC-2001-48-4
Company Name: Pillar Biosciences, Inc.

Primary DI Number: 00860001218251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117965650 *Terms of Use

Device Description: oncoReveal CDx Box 4 of 4. This box contains extra white and orange caps for reagents.

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):	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?
62532	Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine multiple genotypes associated with colorectal cancer, which may include BRAF, KRAS, APC, NRAS, PIK3CA, and/or CTNNB1 gene mutations, using a nucleic acid technique (NAT). It may be used to select treatment options and/or monitor the response to cancer therapy.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8434589f-e4b9-4f02-8269-dcb554b421ff
Public Version Date: April 22, 2024
Public Version Number: 3
DI Record Publish Date: September 20, 2021