Catalog Number

-

Brand Name

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

Version/Model Number

EDTR-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

K121557,K121557,K121557

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Public Device Record Key

f3171ead-e325-481d-836b-6558173773f0

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 20, 2017

Package DI Number

10850253007915

Quantity per Package

40

Contains DI Package

00850253007918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton