Catalog Number

EZW2-S-25

Brand Name

Easy@Home Ovulation Test Strip (25 tests kit)

Version/Model Number

EZW2-S

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"

Yes

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

0d2ffa5a-c1ab-487b-a87f-7b8292c7ecff

Public Version Date

June 26, 2020

Public Version Number

1

DI Record Publish Date

June 18, 2020

Package DI Number

10810038630240

Quantity per Package

120

Contains DI Package

00810038630243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-