Catalog Number

-

Brand Name

AIA-PACK CEA Calibration Verification Test Set

Version/Model Number

N/A

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

-

Product Code

DHX

Product Code Name

System, Test, Carcinoembryonic Antigen

Public Device Record Key

4b13ca88-08be-4833-82cf-c4da9d1dbc9e

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Package DI Number

14560189212241

Quantity per Package

6

Contains DI Package

04560189212244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-