Pillar Biosciences, Inc.

Address:9 Strathmore Road,Natick,MA,01760,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System (PQP) (6)

Premarket Exempt

Clear

oncoReveal Dx Lung and Colon Cancer Assay Box 1 - 00860001218220 Catalog Number : HDA-LC-2001-48-1

Device Description : oncoReveal Dx Lung and Colon Cancer Assay Box 1 of 4. This box contains the Olig 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.

Device Class : 3

Duns Number: 117965650

Premarket Exempt : No

Product Code : PQP

Prescription Use : Yes

Device Count : 1

oncoReveal Dx Lung and Colon Cancer Assay Box 2 - 00860001218237 Catalog Number : HDA-LC-2001-48-2

Device Description : oncoReveal Dx Lung and Colon Cancer Assay Box 2 of 4. This box contains all of t oncoReveal Dx Lung and Colon Cancer Assay Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.

Device Class : 3

Duns Number: 117965650

Premarket Exempt : No

Product Code : PQP

Prescription Use : Yes

Device Count : 1

oncoReveal Dx Lung and Colon Cancer Assay Box 3 - 00860001218244 Catalog Number : HDA-LC-2001-48-3

Device Description : oncoReveal Lung and Colon Cancer Assay Box 3 of 4. This box contains Purification Beads.

Device Class : 3

Duns Number: 117965650

Premarket Exempt : No

Product Code : PQP

Prescription Use : Yes

Device Count : 1

oncoReveal Dx Lung and Colon Cancer Assay Box 4 - 00860001218251 Catalog Number : HDA-LC-2001-48-4

Device Description : oncoReveal Dx Lung and Colon Cancer Assay Box 4 of 4. This box contains extra wh oncoReveal Dx Lung and Colon Cancer Assay Box 4 of 4. This box contains extra white and orange caps for reagents.

Device Class : 3

Duns Number: 117965650

Premarket Exempt : No

Product Code : PQP

Prescription Use : Yes

Device Count : 1

PiVAT Software - 00860001218275 Catalog Number : SFW-2002

Device Description : The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that come 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.

Device Class : 3

Duns Number: 117965650

Premarket Exempt : No

Product Code : PQP

Prescription Use : No

Device Count : 1

oncoReveal Dx Lung and Colon Cancer Assay - 00860001218282 Catalog Number : HDA-LC-2001-4

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

Device Class : 3

Duns Number: 117965650

Premarket Exempt : No

Product Code : PQP

Prescription Use : Yes

Device Count : 1

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