Catalog Number

-

Brand Name

Up & Up

Version/Model Number

Early-Result Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

2174addd-848e-4a77-940a-f3ede474232e

Public Version Date

July 15, 2020

Public Version Number

4

DI Record Publish Date

March 01, 2017

Package DI Number

10855606007048

Quantity per Package

24

Contains DI Package

00855606007041

Package Discontinue Date

January 01, 2020

Package Status

Not in Commercial Distribution

Package Type

Case Pack