Catalog Number

-

Brand Name

Equate

Version/Model Number

One Step Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 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,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

ad5943b4-90a1-4c18-a65a-189232c8e9c4

Public Version Date

September 30, 2019

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

10681131731567

Quantity per Package

24

Contains DI Package

00681131731560

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipping Case