Catalog Number

-

Brand Name

Preview

Version/Model Number

PRE-LH-50S

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NGE

Product Code Name

Test, Luteinizing Hormone (Lh), Over The Counter

Public Device Record Key

b5ff8ab8-5689-471b-a292-b3b581aafcc6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

10816862022459

Quantity per Package

72

Contains DI Package

00816862022452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-