Catalog Number

-

Brand Name

Shopko

Version/Model Number

One Step Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 12, 2019

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

554ed989-d423-4fd7-937a-ae5664d49f63

Public Version Date

December 13, 2019

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

10400103056701

Quantity per Package

24

Contains DI Package

00400103056704

Package Discontinue Date

December 12, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipping Case