Catalog Number

53003

Brand Name

Urine Calibration Standard

Version/Model Number

53003

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

882f9f8a-1eba-487a-9930-49d6c876339c

Public Version Date

May 01, 2019

Public Version Number

1

DI Record Publish Date

April 23, 2019

Package DI Number

04250317538536

Quantity per Package

5

Contains DI Package

04250317544797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-