Catalog Number

-

Brand Name

Detector hCG Personal

Version/Model Number

IDP-25

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

K960174,K960174,K960174

Product Code

LCX

Product Code Name

KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Public Device Record Key

4bb29829-fb5a-4368-bd5d-3926361a2cef

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 28, 2017

Package DI Number

20722355002884

Quantity per Package

20

Contains DI Package

10722355002887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 20