Duns Number:276816717
Device Description: VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to d VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
Catalog Number
-
Brand Name
VIDAS® C. difficile GDH
Version/Model Number
30125-01
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
K132010
Product Code
MCB
Product Code Name
ANTIGEN, C. DIFFICILE
Public Device Record Key
bc5238d8-26bc-4ece-bf49-92c00d53af24
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
November 19, 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 |