Catalog Number

8001-25

Brand Name

AdexusDx hCG Test

Version/Model Number

8001-25

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

K033297,K033297,K033297

Product Code

JHI

Product Code Name

Visual, Pregnancy Hcg, Prescription Use

Public Device Record Key

56277338-50dd-4b35-a5bb-52792aedac2a

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

December 22, 2017

Package DI Number

20858022006203

Quantity per Package

40

Contains DI Package

00858022006209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case