pillar-biosciences.comONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Pillar Biosciences
PILLAR BIOSCIENCES
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3020703032 | 3016560486 | PILLAR BIOSCIENCES | 1 | N | 2026-01-01 | 9 Strathmore Road Natick MA US 01760 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860001218237 | oncoReveal CDx Box 2 - oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix. | 508-655-3027 | snyders@pillar-biosciences.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 295598 | 1624750832 | P200011 | ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) | PQP | 2021-07-30 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PQP | 1 | 2021-07-30 |
PMA#
GUDID#
oncoReveal CDx - oncoReveal CDx - Kit (Boxes 1 through 4)
2021-09-20
PiVAT Software - 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 applicable reports for the oncoReveal CDx
2021-09-20
oncoReveal CDx - oncoReveal CDx Box 4 of 4. This box contains extra white and orange caps for reagents.
2021-09-20
oncoReveal CDx Box 3 - oncoReveal CDx Box 3 of 4. This box contains Purification Beads.
2021-09-20
oncoReveal CDx Box 2 - oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
2021-09-20
oncoReveal CDx - oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
2021-09-20