Catalog Number

EDOAP-144-25

Brand Name

Easy@Home Multi-Drug Screen Test (25 tests kit)

Version/Model Number

EDOAP-144

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

f8a8628b-dc99-4801-8472-59766a330c2a

Public Version Date

July 25, 2022

Public Version Number

4

DI Record Publish Date

June 26, 2020

Package DI Number

10810038631124

Quantity per Package

20

Contains DI Package

00810038631127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton