PiVAT Software SFW-2002

GUDID 00860001218275

The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applciable reports for the oncoReveal Lung and Colon Cancer Assay.

Pillar Biosciences, Inc.

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

• Primary Device ID: 00860001218275
• NIH Device Record Key: f6b3899f-3417-45db-9d7f-82b2dae55f1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PiVAT Software
• Version Model Number: SFW-2002 1.2
• Catalog Number: SFW-2002
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001218275 [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: 2021-09-28 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: 2021-09-28The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applciable reports for the oncoReveal Lung and Colon Cancer Assay.
• 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)