| Primary Device ID | 00860001218282 |
| NIH Device Record Key | 734c3c42-8030-49ce-8c31-577cee9c443b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | oncoReveal Dx Lung and Colon Cancer Assay |
| Version Model Number | HDA-LC-2001-48 |
| Catalog Number | HDA-LC-2001-4 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001218282 [Primary] |
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-28 |
| Device Publish Date | 2021-09-20 |
| 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 | 2021-09-28oncoReveal Dx Lung and Colon Cancer Assay - Kit (Boxes 1 through 4) |
| 00860001218282 - oncoReveal Dx Lung and Colon Cancer Assay | 2021-09-28 oncoReveal Dx Lung and Colon Cancer Assay - Kit (Boxes 1 through 4) |