Catalog Number

-

Brand Name

First Response™ Ovulation Test

Version/Model Number

00022600900542

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K973310,K973310

Product Code

CEP

Product Code Name

RADIOIMMUNOASSAY, LUTEINIZING HORMONE

Public Device Record Key

f8e213a9-33a7-4a93-9b45-585fab470ae6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-