Catalog Number

-

Brand Name

HyVee Health

Version/Model Number

One Step Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 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

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

bfd70c7f-e2c7-48cb-af10-e0172cb2f116

Public Version Date

July 23, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10075450290803

Quantity per Package

24

Contains DI Package

00075450290806

Package Discontinue Date

July 22, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipping Case