Catalog Number

U-DOA-2132

Brand Name

UCP Compact Drug Test Cassette

Version/Model Number

U-DOA-2132

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 23, 2030

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

K050540,K050540,K050540

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

fb14274f-8d13-453c-bf50-c06f07c7e6c5

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 24, 2020

Package DI Number

20817038022034

Quantity per Package

40

Contains DI Package

10817038022037

Package Discontinue Date

June 23, 2030

Package Status

In Commercial Distribution

Package Type

case