Catalog Number

0338

Brand Name

Serum Control

Version/Model Number

0338

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

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Public Device Record Key

066b9319-bfe0-4991-afcc-0ec5d5ab7834

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Package DI Number

04250317539809

Quantity per Package

5

Contains DI Package

04250317546685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-