Duns Number:276816717
Device Description: The VIDAS® 3 system is a complete standalone immunodiagnostic system using VIDAS reagents. The VIDAS® 3 system is a complete standalone immunodiagnostic system using VIDAS reagents.The VIDAS® 3 system is not intended to be used with Industry VIDAS® reagents.
Catalog Number
-
Brand Name
VIDAS® 3
Version/Model Number
412590
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
K141133
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
c6bc0f6f-32e6-4e0b-bda2-c64a2159c0cb
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
September 14, 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 |