Catalog Number

DW2-S

Brand Name

Wondfo

Version/Model Number

DW2-S

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

-

Product Code

NGE

Product Code Name

Test, Luteinizing Hormone (Lh), Over The Counter

Public Device Record Key

c2139d77-6bdc-40e1-97ee-044577be6c84

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 11, 2022

Package DI Number

10816862023692

Quantity per Package

100

Contains DI Package

00816862023695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-