Catalog Number

LCEZ

Brand Name

IMMULITE®/IMMULITE® 1000 Systems CEA CEA Sample Diluent

Version/Model Number

10387047

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

K970877

Product Code

DHX

Product Code Name

SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Public Device Record Key

1d324e09-d906-418d-af31-070880677d16

Public Version Date

September 22, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-