Catalog Number

EZW2-S, EZW1-S

Brand Name

Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips )

Version/Model Number

EZ-WS5020

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

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

3480b527-f578-4cb1-b991-f2ca905f7fbc

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10850253007618

Quantity per Package

60

Contains DI Package

00850253007611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-