Duns Number:021192653
Device Description: AS-322 BRU and BBE/PEA Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacte AS-322 BRU and BBE/PEA Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Phenylethyl Alcohol Blood Agar (PEA) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. PEA is opaque red. 2 plates per pack.
Catalog Number
AS-322
Brand Name
PRAS BRU BBE/PEA Convenience Pack
Version/Model Number
AS-322
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
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
c7daa8e1-0830-4b02-b87a-d6948cc54b58
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 |