Catalog Number

-

Brand Name

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

Version/Model Number

EDOX-114-25

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

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

c50ec09f-5a52-4059-b10e-271f8589997b

Public Version Date

July 25, 2022

Public Version Number

5

DI Record Publish Date

August 02, 2019

Package DI Number

10855944007724

Quantity per Package

35

Contains DI Package

00855944007727

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton