oncoReveal Dx Lung and Colon Cancer Assay Box 1 HDA-LC-2001-48-1

GUDID 00860001218220

oncoReveal Dx Lung and Colon Cancer Assay Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.

Pillar Biosciences, Inc.

Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00860001218220
• NIH Device Record Key: bbd8a57d-69a8-479c-8a56-c38885b7321c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: oncoReveal Dx Lung and Colon Cancer Assay Box 1
• Version Model Number: HDA-LC-2001-48-1
• Catalog Number: HDA-LC-2001-48-1
• Company DUNS: 117965650
• Company Name: Pillar Biosciences, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001218220 [Primary]

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-28
• Device Publish Date: 2021-09-20

Devices Manufactured by Pillar Biosciences, Inc.

• 00860001218220 - oncoReveal Dx Lung and Colon Cancer Assay Box 1: 2021-09-28oncoReveal Dx Lung and Colon Cancer Assay Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
• 00860001218220 - oncoReveal Dx Lung and Colon Cancer Assay Box 1: 2021-09-28 oncoReveal Dx Lung and Colon Cancer Assay Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Gly
• 00860001218237 - oncoReveal Dx Lung and Colon Cancer Assay Box 2: 2021-09-28 oncoReveal Dx Lung and Colon Cancer Assay Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
• 00860001218244 - oncoReveal Dx Lung and Colon Cancer Assay Box 3: 2021-09-28 oncoReveal Lung and Colon Cancer Assay Box 3 of 4. This box contains Purification Beads.
• 00860001218251 - oncoReveal Dx Lung and Colon Cancer Assay Box 4: 2021-09-28 oncoReveal Dx Lung and Colon Cancer Assay Box 4 of 4. This box contains extra white and orange caps for reagents.
• 00860001218275 - PiVAT Software: 2021-09-28 The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to ana
• 00860001218282 - oncoReveal Dx Lung and Colon Cancer Assay: 2021-09-28 oncoReveal Dx Lung and Colon Cancer Assay - Kit (Boxes 1 through 4)