Duns Number:122561087
Device Description: BD BBL™ Chocolate II Agar with Bacitracin
Catalog Number
296271
Brand Name
BD BBL™ Chocolate II Agar with Bacitracin
Version/Model Number
296271
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JTY
Product Code Name
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
Public Device Record Key
72977579-01cc-4d30-b3e3-bef2113e578f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 21, 2016
Package DI Number
30382902962718
Quantity per Package
2
Contains DI Package
10382902962714
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 611 |
2 | A medical device with a moderate to high risk that requires special controls. | 614 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 4 |