Catalog Number

80804/5

Brand Name

Reagent

Version/Model Number

80804/5

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

CDF

Product Code Name

Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

Public Device Record Key

c935ec7f-555e-4e5b-80ec-59818e8e6218

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Package DI Number

04250317537447

Quantity per Package

5

Contains DI Package

04250317546234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-