Duns Number:122561087
Device Description: BD Difco™ QC Antigen Salmonella O Group G1
Catalog Number
211754
Brand Name
BD Difco™ QC Antigen Salmonella O Group G1
Version/Model Number
211754
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
GRL
Product Code Name
ANTIGENS, ALL GROUPS, SALMONELLA SPP.
Public Device Record Key
aff3bcb5-b7a9-4b1c-a1eb-53e3dd6811f3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 07, 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 |