Catalog Number

-

Brand Name

PreKnow Pregnancy Test (25 hCG Strips)

Version/Model Number

ID1-S-25P

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

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

995bd9be-68ac-475e-ac90-af1e9756c82c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 16, 2017

Package DI Number

00857275007001

Quantity per Package

25

Contains DI Package

00857275007100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

25 HCG Strips