Catalog Number

HDA-LC-2001-4

Brand Name

oncoReveal Dx Lung and Colon Cancer Assay

Version/Model Number

HDA-LC-2001-48

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PQP

Product Code Name

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

Public Device Record Key

734c3c42-8030-49ce-8c31-577cee9c443b

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-