Catalog Number

EDOAP-295-25

Brand Name

Easy@Home 9 Panel Instant Urine Drug Test (25 test kit)

Version/Model Number

EDOAP-295

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133968,K133968,K133968

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

d6c9041e-3e36-4c15-8c1d-5a34cb6a8dbc

Public Version Date

October 31, 2022

Public Version Number

5

DI Record Publish Date

July 01, 2018

Package DI Number

10855944007410

Quantity per Package

20

Contains DI Package

00855944007413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton