ihcDirect® E-Cadherin Ab, 15mL - Clone R1005 - NOVODIAX, INC.

Duns Number:965326957

Device Description: Clone R1005

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ihcDirect® E-Cadherin Ab, 15mL

Version/Model Number

K32036-015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2021

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NJT

Product Code Name

Immunohistochemistry Reagents And Kits

Device Record Status

Public Device Record Key

f871658a-bc67-4d58-8c08-e1b9ecaea9d3

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

April 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVODIAX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 245