Catalog Number

-

Brand Name

First Response™ Pregnancy Triple Check Pregnancy Test Kit

Version/Model Number

00061700900700

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

K123436,K123567,K973352

Product Code

LCX

Product Code Name

KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Public Device Record Key

efbbf763-e172-416d-9ffd-f4801c89af13

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-