Catalog Number

88121

Brand Name

UTAK Urine Drug Screen

Version/Model Number

88121

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LAS

Product Code Name

Drug Specific Control Materials

Public Device Record Key

4a2014c7-9557-4017-9d51-3cee5d9a7b55

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Package DI Number

B800881215

Quantity per Package

5

Contains DI Package

B800881210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box