Duns Number:276816717
Device Description: The VIDAS®3 can perform dilutions and manage two dilution cup racks holding 16 cups each.
Catalog Number
-
Brand Name
VIDAS® 3 ASSAY DILUTION CUP
Version/Model Number
VIDAS® 3 ASSAY DILUTION CUP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141133,K141133
Product Code
JJE
Product Code Name
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Public Device Record Key
124b1ee7-0a9c-46f5-be6c-04cfd0aacb9f
Public Version Date
September 26, 2022
Public Version Number
3
DI Record Publish Date
May 28, 2020
Package DI Number
03573026377427
Quantity per Package
44
Contains DI Package
03573026612849
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |