Catalog Number

EZU-101-20

Brand Name

Easy@Home Urinary Tract Infection Test Strips (20 Pack)

Version/Model Number

EZU-101

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

K063295,K063295

Product Code

JMT

Product Code Name

Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

Public Device Record Key

6b35e319-814a-4413-8d9d-469756c6dc1d

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-