Catalog Number

-

Brand Name

e.p.t. Digital Early Pregnancy Test

Version/Model Number

EPT Digital

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

K061769,K061769,K061769

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

94fcab20-fe37-4010-853e-e44e66a5fc1a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10363736992023

Quantity per Package

12

Contains DI Package

00363736992026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping case