Duns Number:276816717
Device Description: The Serum free reagent can be used with VIDAS ® assays for which its use is clearly indica The Serum free reagent can be used with VIDAS ® assays for which its use is clearly indicated in the VIDAS assay package insert.
Catalog Number
-
Brand Name
VIDAS® Serum Free
Version/Model Number
VIDAS® Serum Free
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
K931031,K931031
Product Code
JFT
Product Code Name
Fluorometric, Cortisol
Public Device Record Key
bdeab528-2826-49e8-8279-d7c3073d0966
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
03573026097295
Quantity per Package
2
Contains DI Package
03573026551469
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 |