Catalog Number

-

Brand Name

Smart Sense Early Result Pregnancy Test

Version/Model Number

PLPL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2021

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

4deca5c6-5480-4729-8ca2-198342e1b059

Public Version Date

April 20, 2021

Public Version Number

4

DI Record Publish Date

July 04, 2016

Package DI Number

10072000793135

Quantity per Package

24

Contains DI Package

00072000793138

Package Discontinue Date

April 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipping Case