Catalog Number

EDCO-114-25

Brand Name

Easy@Home COC Single Drug Screen Test (25 tests kit)

Version/Model Number

EDCO-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)

-

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

dad7f444-ccf8-4f62-a434-824e5ac6d526

Public Version Date

October 31, 2022

Public Version Number

5

DI Record Publish Date

June 29, 2020

Package DI Number

10810038631407

Quantity per Package

20

Contains DI Package

00810038631400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton