Catalog Number

635

Brand Name

Pantex P635ST

Version/Model Number

P635ST

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

-

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

-

Product Code

CDZ

Product Code Name

Radioimmunoassay, Testosterones And Dihydrotestosterone

Public Device Record Key

a3dded3a-b4c8-4fcd-960e-8b9780be1597

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Package DI Number

10850039602235

Quantity per Package

1

Contains DI Package

00850039602238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box