Catalog Number

-

Brand Name

HER2 IQFISH pharmDx™

Version/Model Number

K5731

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MVD

Product Code Name

System, Test, Her-2/Neu, Nucleic Acid Or Serum

Public Device Record Key

22d4b094-db5e-45cf-8253-3c4dbb5f0846

Public Version Date

December 07, 2020

Public Version Number

7

DI Record Publish Date

September 15, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-