Catalog Number

EDTH-114-12

Brand Name

Easy@Home Single Drug Screen Test (Marijuana Urine Test)

Version/Model Number

EDTH-114

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"

-

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

K161044,K161044

Product Code

DJC

Product Code Name

Thin Layer Chromatography, Methamphetamine

Public Device Record Key

04beba97-68c2-44c1-bd2b-c2b70e658434

Public Version Date

August 01, 2022

Public Version Number

3

DI Record Publish Date

April 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-