Duns Number:276816717
Device Description: VIDAS PC V4.9 W10 Software version for clinic
Catalog Number
-
Brand Name
VIDAS
Version/Model Number
4.9
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
K891385
Product Code
DEW
Product Code Name
IGG, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
7f6f8d7e-574a-4a8c-8b98-2242ac835221
Public Version Date
December 30, 2019
Public Version Number
1
DI Record Publish Date
December 20, 2019
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 |