Catalog Number

-

Brand Name

Oncomine™ Dx Target Test

Version/Model Number

A32441

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

P160045,P160045

Product Code

PQP

Product Code Name

Next generation sequencing oncology panel, somatic or germline variant detection system

Public Device Record Key

6d0fab78-a58c-4663-b4cd-7fe1f9f68b2a

Public Version Date

November 16, 2020

Public Version Number

5

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-