Catalog Number

-

Brand Name

Publix One Step Pregnancy Test

Version/Model Number

FPPL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 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

c063933d-f3e6-49da-8ce0-123722dcdee7

Public Version Date

February 12, 2021

Public Version Number

4

DI Record Publish Date

August 10, 2016

Package DI Number

10041415024769

Quantity per Package

12

Contains DI Package

00041415024762

Package Discontinue Date

February 11, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipping Case