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

760c9bee-4fa9-4842-ac51-f8fbc26e4b78

Public Version Date

April 25, 2019

Public Version Number

1

DI Record Publish Date

April 17, 2019

Package DI Number

10633472601894

Quantity per Package

6

Contains DI Package

00633472601897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case