Duns Number:122561087
Device Description: BD BBL™ Crystal™ Gram-Positive ID System Contains: 20 each, Panel Lids, Panel BD BBL™ Crystal™ Gram-Positive ID System Contains: 20 each, Panel Lids, Panel Bases, Inoculum Fluid
Catalog Number
245240
Brand Name
BD BBL™ Crystal™ Gram-Positive ID System
Version/Model Number
245240
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
LQL
Product Code Name
GRAM POSITIVE IDENTIFICATION PANEL
Public Device Record Key
f58bdcd0-2c99-42b5-901a-97d1006f0e80
Public Version Date
June 25, 2018
Public Version Number
1
DI Record Publish Date
May 25, 2018
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 | 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 |