Catalog Number

EZ-WS10040

Brand Name

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

Version/Model Number

EZW2-S, EZW1-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"

-

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

6c114f48-2626-4e3a-bae2-6b782046efed

Public Version Date

July 06, 2020

Public Version Number

1

DI Record Publish Date

June 26, 2020

Package DI Number

10810038631414

Quantity per Package

30

Contains DI Package

00810038631417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton