Catalog Number

32003

Brand Name

Serum Calibration Standard

Version/Model Number

32003

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

JIT

Product Code Name

Calibrator, Secondary

Public Device Record Key

ed6fdaf9-d013-401e-bede-666d264ecf9c

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

March 22, 2019

Package DI Number

04250317505804

Quantity per Package

5

Contains DI Package

04250317543547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-