Catalog Number

5741855

Brand Name

LEADER

Version/Model Number

5741855

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

K150022,K150022

Product Code

LCX

Product Code Name

KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Public Device Record Key

4ed6baa5-9dc5-4b39-a2b5-09af109f431e

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

50096295141516

Quantity per Package

24

Contains DI Package

00096295141511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE