Catalog Number

22005/HR

Brand Name

Serum Calibration Standard

Version/Model Number

22005/HR

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

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Public Device Record Key

5f6a420f-55db-4c3b-85c3-2435657778ff

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 22, 2019

Package DI Number

04250317503572

Quantity per Package

5

Contains DI Package

04250317543394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-