Catalog Number

-

Brand Name

Clearblue

Version/Model Number

Reassurance Pregnancy Test with Color Change Tip

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 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

K040341,K040341,K040341

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

2b2037cd-489f-47b6-8422-cfa0e217dcfa

Public Version Date

August 10, 2022

Public Version Number

4

DI Record Publish Date

February 26, 2018

Package DI Number

10633472601320

Quantity per Package

24

Contains DI Package

00633472601323

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

Shipping case