Catalog Number

-

Brand Name

Clearblue

Version/Model Number

Connected Ovulation Test System

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

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

599cf8c9-2518-44e0-8470-da4b4b52b67a

Public Version Date

March 15, 2019

Public Version Number

3

DI Record Publish Date

May 24, 2018

Package DI Number

10633472601207

Quantity per Package

6

Contains DI Package

00633472601200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case