Catalog Number

K31007-005

Brand Name

ihcDirect® AE1/AE3 Abs

Version/Model Number

K31007-005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 10, 2026

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

036fa8e1-02dd-453d-8d40-63c0d66edc72

Public Version Date

September 03, 2021

Public Version Number

3

DI Record Publish Date

June 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-