Duns Number:122561087
Device Description: BD BBL™ GC-Lect™ Agar
Catalog Number
297928
Brand Name
BD BBL™ GC-Lect™ Agar
Version/Model Number
297928
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
K864803,K864803,K864803
Product Code
JTY
Product Code Name
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
Public Device Record Key
5714b636-b4d4-460c-94be-35028ac999da
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 21, 2016
Package DI Number
30382902979280
Quantity per Package
10
Contains DI Package
10382902979286
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 |