Catalog Number

U-CUP-564

Brand Name

U-Cup TM Drug Test Screen

Version/Model Number

U-CUP-564

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"

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

-

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

be737dc7-4129-4c12-b2be-90f88ba3fd98

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2017

Package DI Number

20817038021945

Quantity per Package

8

Contains DI Package

10817038021948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case