Catalog Number

U-MCUP-154

Brand Name

UCP Drug Test Mini Cups

Version/Model Number

U-MCUP-154

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 24, 2032

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151213,K151213,K151213

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

33581631-da6e-4281-8604-b2cf7027f444

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 25, 2022

Package DI Number

20817038022102

Quantity per Package

4

Contains DI Package

10817038022105

Package Discontinue Date

April 24, 2032

Package Status

In Commercial Distribution

Package Type

case