oncoReveal Dx Lung and Colon Cancer Assay

Basic Information

• Brand Name: oncoReveal Dx Lung and Colon Cancer Assay
• Primary DI: 00860001218282
• Version / Model: HDA-LC-2001-48
• Catalog Number: HDA-LC-2001-4
• Company Name: Pillar Biosciences, Inc.
• Labeler DUNS: 117965650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-20
• Public Version: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 734c3c42-8030-49ce-8c31-577cee9c443b

Device Description

oncoReveal Dx Lung and Colon Cancer Assay - Kit (Boxes 1 through 4)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQP	Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001218282	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]