Catalog Number

-

Brand Name

Clearblue Advanced Digital Pregnancy Test with Weeks Estimator

Version/Model Number

CB9a

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2017

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

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

52289fb8-abaa-4074-9b0e-018a64239a6a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 30, 2016

Package DI Number

10633472600569

Quantity per Package

24

Contains DI Package

00633472600562

Package Discontinue Date

January 28, 2017

Package Status

Not in Commercial Distribution

Package Type

Shipping Case