Catalog Number

-

Brand Name

Care One One Step Pregnancy Test

Version/Model Number

FPPL

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)

-

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

2c002b4d-c754-45b1-9bf1-12845434793f

Public Version Date

April 26, 2022

Public Version Number

4

DI Record Publish Date

July 25, 2016

Package DI Number

10041520863550

Quantity per Package

24

Contains DI Package

00041520863553

Package Discontinue Date

April 14, 2022

Package Status

Not in Commercial Distribution

Package Type

Shipping Case