Duns Number:039981550
Device Description: C. diff PRO, a rapid proline and indole test for Clostridioides difficile, 25 test cards, C. diff PRO, a rapid proline and indole test for Clostridioides difficile, 25 test cards, 1 reagent, 16oz jarC. diff PRO™ Test Kit is recommended for use in screening suspected Clostridioides difficile isolates for L-proline aminopeptidase activity and a lack of indole activity.The test performs a proline separately from indole for a clear test interpretation.Developing Reagent (1) 00819398028585C. diff PRO Card (25) 00819398027113
Catalog Number
Z120
Brand Name
N/A
Version/Model Number
Z120
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LIB
Product Code Name
Device, General Purpose, Microbiology, Diagnostic
Public Device Record Key
77e339f3-11d4-4fb2-9b4f-92bc142bc8b1
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |