Catalog Number

5009

Brand Name

Plasma Calibration Standard

Version/Model Number

5009

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

948cf73e-a560-4700-a4fb-8ffd5e383296

Public Version Date

April 09, 2019

Public Version Number

2

DI Record Publish Date

March 22, 2019

Package DI Number

04250317511348

Quantity per Package

5

Contains DI Package

04250317543806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-