Catalog Number

-

Brand Name

Clearblue

Version/Model Number

Digital Pregnancy Test

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

-

Product Code

NGE

Product Code Name

Test, Luteinizing Hormone (Lh), Over The Counter

Public Device Record Key

ecfd2f29-660b-476a-a9de-5fc235cfcf8a

Public Version Date

August 06, 2019

Public Version Number

1

DI Record Publish Date

July 29, 2019

Package DI Number

10633472276894

Quantity per Package

6

Contains DI Package

00633472276897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case