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

MR Conditional

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

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

eabe5eff-bc26-4a07-a2e7-f558947f5371

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-