Catalog Number

-

Brand Name

Winco Foods

Version/Model Number

One Step Pregnancy Test

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

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

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

afecf88c-0b6a-49fb-8167-1037aad524ee

Public Version Date

February 05, 2020

Public Version Number

1

DI Record Publish Date

January 28, 2020

Package DI Number

10070552250960

Quantity per Package

24

Contains DI Package

00070552250963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping case