Catalog Number

-

Brand Name

Clearblue

Version/Model Number

Advanced Period Tracker

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

fefa7126-a30f-43a8-8705-c7f3fb128851

Public Version Date

December 02, 2021

Public Version Number

1

DI Record Publish Date

November 24, 2021

Package DI Number

10633472602099

Quantity per Package

24

Contains DI Package

00633472602092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper