Catalog Number

EDTH-114-12

Brand Name

Easy@Home THC Single Drug Screen Test (12 tests kit)

Version/Model Number

EDTH-114

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2022

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

K121557,K121557

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Public Device Record Key

10ae9fe3-0d0b-4ebe-86ce-64fcccff7bc4

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

July 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-