Catalog Number

-

Brand Name

Good Sense One Step Pregnancy Test

Version/Model Number

FPPL

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,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

f3bd94e4-5dc0-424c-9957-c2c6bca629ef

Public Version Date

April 20, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2016

Package DI Number

10846036006404

Quantity per Package

24

Contains DI Package

00846036006407

Package Discontinue Date

April 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipping Case