Catalog Number

EZW2-S, EZW1-S

Brand Name

Easy@Home Ovulation Test Kit (100 LH strips + 40 HCG strips )

Version/Model Number

EZ-WS10040

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

f2c32973-b48a-4fa0-ab66-00710f44cb0c

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10850253007625

Quantity per Package

30

Contains DI Package

00850253007628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-