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

June 06, 2022

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,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

7a2da524-b12e-4067-91ee-8644e168df60

Public Version Date

June 07, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

10846036009184

Quantity per Package

24

Contains DI Package

00846036009187

Package Discontinue Date

June 06, 2022

Package Status

Not in Commercial Distribution

Package Type

Shipping case