Catalog Number

80009

Brand Name

Reagent

Version/Model Number

80009

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

CHQ

Product Code Name

Chromatographic/Fluorometric Method, Catecholamines

Public Device Record Key

5a1da3fe-fd7e-4448-841d-24f7016d24af

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-