Catalog Number

U-CUP-384

Brand Name

u-Cup TM Drug Test Screen 8 Panel Drug Test Cup

Version/Model Number

U-CUP-384

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

K131811,K131811,K131811

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

62226eaa-987c-443f-bb6e-f5c35dbdff00

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 01, 2018

Package DI Number

20817038021969

Quantity per Package

8

Contains DI Package

10817038021962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case