Duns Number:021192653
Device Description: AS-808 Brucella Agar Deep CLSI 19 mL (BRU DEEP CLSI 19mL), with the addition of blood, is AS-808 Brucella Agar Deep CLSI 19 mL (BRU DEEP CLSI 19mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 19 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.
Catalog Number
AS-808
Brand Name
PRAS Brucella Agar Deep CLSI Formulation 19mL (BRU DEEP CLSI 19mL)
Version/Model Number
AS-808
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
df30f2c5-7823-43fb-b2f7-b4cb9e0862b3
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 |