Catalog Number

5741889

Brand Name

LEADER

Version/Model Number

5741889

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

K984075,K984075,K984075

Product Code

LCX

Product Code Name

KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Public Device Record Key

17c38be2-1692-4cc6-b9bb-09d384f330d3

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

50096295141547

Quantity per Package

24

Contains DI Package

00096295141542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE