Duns Number:021192653
Device Description: AS-614 Brucella Blood agar (BRU) is intended for the isolation, quantitation, and partial AS-614 Brucella Blood agar (BRU) is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will also support the growth of aerobic and microaerophilic bacteria if incubated appropriately. BRU is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 150 x 15 mm agar plate. Opaque burgundy red. 1 plate per pack.
Catalog Number
AS-614
Brand Name
PRAS Brucella Blood Agar (BRU)
Version/Model Number
AS-614
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
cf85ddc7-6803-4d18-9d70-064ed41a255c
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 |