Catalog Number

EZR-101-100

Brand Name

Easy@Home KetoneTest Strips (100 test kit)

Version/Model Number

EZR-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

-

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Public Device Record Key

c31af5b5-4429-48a3-b951-1bf50d8109ba

Public Version Date

August 01, 2018

Public Version Number

1

DI Record Publish Date

July 01, 2018

Package DI Number

10855944007236

Quantity per Package

24

Contains DI Package

00855944007239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton