Catalog Number

-

Brand Name

Good Sense

Version/Model Number

One Step Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 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

K042280,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

3775aa51-cf50-4788-a308-19ae3d70abfa

Public Version Date

April 20, 2021

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

10846036009177

Quantity per Package

24

Contains DI Package

00846036009170

Package Discontinue Date

April 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipping case