Duns Number:021192653
Device Description: AS-6061 Reinforced Clostridial Agar (RCA) is an enriched non-selective medium intended for AS-6061 Reinforced Clostridial Agar (RCA) is an enriched non-selective medium intended for the cultivation of Clostridia and other anaerobic and facultative bacteria from various clinical and non-clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow. 4 plates per pack.
Catalog Number
AS-6061
Brand Name
PRAS Reinforced Clostridial Agar (RCA)
Version/Model Number
AS-6061
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
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
fd253553-ab6d-4f2c-b7fa-5015c2882813
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 |