Catalog Number

LPEZ

Brand Name

IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide Sample Diluent

Version/Model Number

10387039

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

K943767

Product Code

JKD

Product Code Name

RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN

Public Device Record Key

75cd8001-6bbe-4bb6-912b-525a8375861c

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

-