Catalog Number

-

Brand Name

Good Neighbor Pharmacy

Version/Model Number

One Step Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 14, 2022

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)

Yes

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

a432b33c-324e-4082-aaef-cadfab6b6da9

Public Version Date

August 08, 2022

Public Version Number

3

DI Record Publish Date

November 29, 2019

Package DI Number

10087701432207

Quantity per Package

24

Contains DI Package

00087701432200

Package Discontinue Date

April 14, 2022

Package Status

Not in Commercial Distribution

Package Type

Shipping case