Duns Number:122561087
Device Description: BD Difco™ Neisseria Meningitidis Antiserum Poly Contains Groups A, B, C, D
Catalog Number
222321
Brand Name
BD Difco™ Neisseria Meningitidis Antiserum Poly Contains Groups A, B, C, D
Version/Model Number
222321
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
GTJ
Product Code Name
ANTISERA, ALL GROUPS, N. MENINGITIDIS
Public Device Record Key
541e54c1-d972-4c97-956f-a9eb6662518a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 28, 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 |