Catalog Number

LDSZ

Brand Name

IMMULITE®/IMMULITE® 1000 Systems DHS DHEASO4 Sample Diluent

Version/Model Number

10387020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K935806

Product Code

JKC

Product Code Name

RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

Public Device Record Key

ccac07d2-674f-4606-abe8-c286cbc8d392

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

-