Catalog Number

-

Brand Name

Modern Fertility Pregnancy Test

Version/Model Number

A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

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

K150022

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

524d5a49-04f5-41d4-b77c-95dc78aa5a4a

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

July 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-