Duns Number:080778937
Device Description: The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed i The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
Catalog Number
20-006-022
Brand Name
Clostridium difficile (CDF) Nucleic Acid Test Cartridge
Version/Model Number
20-006-022
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
K123197,K123197
Product Code
OZN
Product Code Name
C. Difficile toxin gene amplification assay
Public Device Record Key
c06d338b-0611-49d3-a9e0-e1a3d3a4b33e
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
December 05, 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 | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |