Catalog Number

-

Brand Name

Health Mart Pharmacy One Step Pregnancy Test

Version/Model Number

FPPL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2020

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

54e6d162-9a89-422e-aaf1-f9f7f48d2704

Public Version Date

June 11, 2020

Public Version Number

5

DI Record Publish Date

June 30, 2016

Package DI Number

10052569139025

Quantity per Package

24

Contains DI Package

00052569139028

Package Discontinue Date

January 27, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping Case