Catalog Number

W1-MII

Brand Name

Wondfo Pregnancy Test

Version/Model Number

W1-MII

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)

Yes

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

52fbb97a-9572-4994-92c9-b6bef472d82a

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10816862020363

Quantity per Package

20

Contains DI Package

00816862020366

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-