Catalog Number

-

Brand Name

Meijer

Version/Model Number

One Step Pregnancy Tests

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

2ed2d3f2-2ed4-4a2e-bcbd-0ea12ee7dcd8

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

10713733804780

Quantity per Package

24

Contains DI Package

00713733804783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping case