Catalog Number

LINZ

Brand Name

IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample Diluent

Version/Model Number

10387034

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

-

Product Code

CFP

Product Code Name

RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Public Device Record Key

5a4ac3a7-0e85-43c7-a357-d7526bca0810

Public Version Date

September 22, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-