Catalog Number

U-OPI-114L

Brand Name

u-Card Drug Test Screen

Version/Model Number

U-OPI-114L

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

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

0c11e17d-43d0-4747-9de1-2602ed504e29

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 20, 2017

Package DI Number

20817038021822

Quantity per Package

40

Contains DI Package

10817038021825

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case