Catalog Number

EZW2-M , EZW1-M

Brand Name

Easy@Home Ovulation Test Kit (8 LH Midstreams+ 2 HCG Midstreams)

Version/Model Number

EZM1-L8H2

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

73d32539-8645-4692-a288-6205fd1201c6

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10850253007687

Quantity per Package

70

Contains DI Package

00850253007680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-