Duns Number:276816717
Device Description: VIDAS ® CEA (S) (CEAS) is an automated quantitative test for use on the VIDAS instruments VIDAS ® CEA (S) (CEAS) is an automated quantitative test for use on the VIDAS instruments for the measurement of Carcinoembryonic antigen (CEA) in human serum.
Catalog Number
-
Brand Name
VIDAS® CEA (S)
Version/Model Number
30453-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 17, 2017
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
fcc45d44-cba6-465d-9701-cf184e179f9b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |