Catalog Number

-

Brand Name

Clinical Guard

Version/Model Number

LH40 and HCG 10 Combo

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

Yes

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

af2c1c06-d365-40b9-abd3-f4c6c578c809

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 19, 2017

Package DI Number

10897429002701

Quantity per Package

100

Contains DI Package

00897429002704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-