Duns Number:021192653
Device Description: AS-2133 Cycloserine Cefoxitin Fructose Agar with Lysozyme (CCFA-L) is an enriched, selecti AS-2133 Cycloserine Cefoxitin Fructose Agar with Lysozyme (CCFA-L) is an enriched, selective, and differential media used for the isolation and presumptive identification of Clostridioides difficile. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent red/orange. 1 plate per pack.
Catalog Number
AS-2133
Brand Name
PRAS Cycloserine Cefoxitin Fructose Agar with Lysozyme (CCFA-L)
Version/Model Number
AS-2133
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
f0593327-1954-464e-a880-ca6c01adf1fd
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 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 | 148 |