Catalog Number

-

Brand Name

MAS UrichemTRAK Liquid Assayed Urine Control

Version/Model Number

UR11001

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

Yes

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

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Public Device Record Key

c98182fb-e481-40f0-b60d-bf6995ff3b34

Public Version Date

April 29, 2019

Public Version Number

4

DI Record Publish Date

April 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-