Catalog Number

EZW2-M

Brand Name

Easy@Home Ovulation Test Midstream (15 tests kit)

Version/Model Number

EZM1-L15

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

3be10989-4fea-4871-bfe2-d2e8f1cdc1bc

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

December 23, 2016

Package DI Number

10850253007854

Quantity per Package

56

Contains DI Package

00850253007857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton