Catalog Number

U-MET-114L

Brand Name

u-Card Drug Test Screen

Version/Model Number

U-MET-114L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 15, 2032

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

DJC

Product Code Name

Thin Layer Chromatography, Methamphetamine

Public Device Record Key

ca9b2294-2a3c-4007-89b6-0b5897516dba

Public Version Date

June 24, 2022

Public Version Number

1

DI Record Publish Date

June 16, 2022

Package DI Number

20817038022119

Quantity per Package

40

Contains DI Package

10817038022112

Package Discontinue Date

June 14, 2032

Package Status

In Commercial Distribution

Package Type

case