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

July 17, 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

K042280,K042280,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

8bcf402b-19d9-442c-84fc-f0d1a7821906

Public Version Date

July 20, 2020

Public Version Number

4

DI Record Publish Date

February 12, 2018

Package DI Number

10492450308602

Quantity per Package

12

Contains DI Package

00492450308605

Package Discontinue Date

July 17, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping Case