Catalog Number

EDOAP-754-10

Brand Name

Easy@Home Multi-Drug Screen Test (10 tests kit)

Version/Model Number

EDOAP-754

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

91061cad-caba-48af-bb40-d27c74739808

Public Version Date

July 25, 2022

Public Version Number

3

DI Record Publish Date

October 28, 2021

Package DI Number

10810038631681

Quantity per Package

60

Contains DI Package

00810038631684

Package Discontinue Date

October 22, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton