Duns Number:021192653
Device Description: AS-212 BBE/LKV Bacteroides Bile Esculin (BBE) agar is an enriched, selective, and differen AS-212 BBE/LKV Bacteroides Bile Esculin (BBE) agar is an enriched, selective, and differential medium used for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila wadsworthia. Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV) is an enriched, selective, and differential medium for the isolation and partial identification of obligately anaerobic gram-negative bacilli. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm split plate. BBE is transparent yellow/green. LKV is transparent red. 1 plate
Catalog Number
AS-212
Brand Name
PRAS BBE/LKV Biplate
Version/Model Number
AS-212
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
c37377c7-3f50-4b37-8fcc-f717b9f7301a
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 |