Catalog Number

EZW2-S, EZW1-S

Brand Name

Easy@Home Ovulation Test Kit (25 LH strips + 25 HCG strips )

Version/Model Number

EZ-WS2525

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2022

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

596bc395-3e93-4649-8634-d44293861e84

Public Version Date

April 06, 2022

Public Version Number

5

DI Record Publish Date

May 05, 2017

Package DI Number

10855944007021

Quantity per Package

80

Contains DI Package

00855944007024

Package Discontinue Date

April 06, 2022

Package Status

Not in Commercial Distribution

Package Type

carton