Access CEA QC - The Access CEA QC (BSA matrix) controls are - Beckman Coulter, Inc.

Duns Number:008254708

Device Description: The Access CEA QC (BSA matrix) controls are intended for monitoring the system performance The Access CEA QC (BSA matrix) controls are intended for monitoring the system performance of immunoenzymatic procedures for the quantitative measurement of Carcinoembryonic Antigen (CEA) using Access CEA reagents.

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More Product Details

Catalog Number

33209

Brand Name

Access CEA QC

Version/Model Number

33209

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DHX

Product Code Name

System, Test, Carcinoembryonic Antigen

Device Record Status

Public Device Record Key

9080aa52-9f2a-4ddf-a84d-ecf9ba59957a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECKMAN COULTER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319
2 A medical device with a moderate to high risk that requires special controls. 503
3 A medical device with high risk that requires premarket approval 9
U Unclassified 1