Catalog Number

-

Brand Name

Exchange Select

Version/Model Number

One Step Pregnancy Test

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

K042280,K042280,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

183f1660-cac6-42d8-a798-338f8ecef536

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Package DI Number

10614299437385

Quantity per Package

24

Contains DI Package

00614299437388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case