Catalog Number

-

Brand Name

PATHWAY HER-2 4 in 1 Control Slides

Version/Model Number

10 slides

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

NJT

Product Code Name

IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Public Device Record Key

e65ba0d3-2e86-4266-9f15-ca5eb730a812

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-