Catalog Number

87039

Brand Name

Whole Blood Calibration Standard

Version/Model Number

87039

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

3ee1bfc3-2946-4147-9d94-680e01dec03e

Public Version Date

March 13, 2020

Public Version Number

1

DI Record Publish Date

March 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-