Catalog Number

-

Brand Name

INFORM HER2 Dual ISH DNA Probe Cocktail

Version/Model Number

50 tests

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

NYQ

Product Code Name

Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer

Public Device Record Key

c64879d5-c6db-4ad3-b630-682fdbb804e7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-