Duns Number:039981550
Device Description: Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplat Brucella Agar with Hemin and Vitamin K /LKV (Laked Blood Kanamycin Vancomycin) Agar Biplate, 15x100 biplate, 10/pkFor the cultivation of anaerobic bacteria and the selective isolation of Bacteroides spp.
Catalog Number
J87
Brand Name
N/A
Version/Model Number
J67
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
1e5f774c-a9bd-44f4-a55b-65ff6851ccb3
Public Version Date
September 03, 2020
Public Version Number
2
DI Record Publish Date
June 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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |