Catalog Number

K47042-005

Brand Name

ihcDirect® PRAME Ab-Enh, 5mL

Version/Model Number

K47042-005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2021

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

d9056b6b-ca62-49d5-83eb-b48c8193021f

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

October 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-