Duns Number:122561087
Device Description: BD Difco™ BBL™ Francisella Tularensis Antiserum
Catalog Number
240939
Brand Name
BD Difco™ BBL™ Francisella Tularensis Antiserum
Version/Model Number
240939
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
GSK
Product Code Name
ANTISERUM, FRANCISELLA TULARENSIS
Public Device Record Key
6c32c889-4ffd-41e4-a4cd-4d190a6772d6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 19, 2016
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 |