Catalog Number

LKTW1

Brand Name

IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone

Version/Model Number

10381156

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032881

Product Code

CDZ

Product Code Name

RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Public Device Record Key

a2794e69-83bd-4919-a9fe-7e4d5a462d93

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-