Catalog Number

EZR-101-150

Brand Name

Easy@Home KetoneTest Strips (150 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

230bfadf-d4aa-4512-aa7b-4afa2cf5ab8c

Public Version Date

July 27, 2018

Public Version Number

1

DI Record Publish Date

June 26, 2018

Package DI Number

10855944007229

Quantity per Package

24

Contains DI Package

00855944007222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton