Catalog Number

-

Brand Name

Preview

Version/Model Number

PRE-HCG-30CC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072500,K072500

Product Code

DHA

Product Code Name

System, Test, Human Chorionic Gonadotropin

Public Device Record Key

0faae1fa-2ed8-4d03-954e-cef12507cb92

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

March 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-