Duns Number:276816717
Device Description: The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
Catalog Number
-
Brand Name
VIDAS® C. difficile Toxin A & B
Version/Model Number
30118-01
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
K080931
Product Code
LLH
Product Code Name
REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN
Public Device Record Key
d422473d-7b74-4254-8f22-116dc9c52595
Public Version Date
November 18, 2019
Public Version Number
1
DI Record Publish Date
November 08, 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 |