Duns Number:008254708
Device Description: The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilut The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilute patient samples containing CEA concentrations greater than the Access CEA Calibrator S5
Catalog Number
33206
Brand Name
Access CEA Diluent
Version/Model Number
33206
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)
Yes
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
c6546811-7615-41d4-ad00-10356c559e92
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |