Catalog Number

-

Brand Name

Clearblue Pregnancy Test with Smart Countdown

Version/Model Number

CB12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K060128,K060128,K060128

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

f5b78223-db11-4100-ade0-e244b86210aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 30, 2016

Package DI Number

00633472052958

Quantity per Package

24

Contains DI Package

00633472002953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case