Catalog Number

W1-MP3

Brand Name

Preview Pregnancy Test

Version/Model Number

W1-MP3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K043443,K043443,K043443

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

a972e2fc-cb37-416b-b2f8-b947e5b71686

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

10864112000214

Quantity per Package

100

Contains DI Package

00864112000217

Package Discontinue Date

January 01, 2019

Package Status

Not in Commercial Distribution

Package Type

-