Catalog Number

-

Brand Name

Applied Biosystems

Version/Model Number

187265

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2018

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)

Yes

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

3aacc90c-6641-43e4-9383-d5bc85b4e7e3

Public Version Date

June 19, 2018

Public Version Number

3

DI Record Publish Date

February 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-