Catalog Number

U-DOA-654

Brand Name

u-CardTM Drug Test Screen

Version/Model Number

U-DOA-654

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 08, 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

K131811,K131811,K131811

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

729b227b-4ae4-4c39-b0a1-7bd915b85101

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 09, 2020

Package DI Number

20817038022058

Quantity per Package

40

Contains DI Package

10817038022051

Package Discontinue Date

November 08, 2030

Package Status

In Commercial Distribution

Package Type

case