Catalog Number

-

Brand Name

Easy@Home Pregnancy Test Strip (40 tests kit)

Version/Model Number

EZW1-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

K043443,K043443,K043443,K043443

Product Code

-

Product Code Name

-

Public Device Record Key

fd444b71-5346-4778-aecc-99218f065c1a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 23, 2016

Package DI Number

10850253007847

Quantity per Package

120

Contains DI Package

00850253007840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton