Duns Number:122561087
Device Description: Vial Qc Antigen Sal O Group E1 1Ml
Catalog Number
211750
Brand Name
BD Difco™ QC Antigen Salmonella O Group E1
Version/Model Number
211750
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 29, 2021
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
0b5511a3-a6ae-452b-8cb9-b16c97aee251
Public Version Date
July 15, 2022
Public Version Number
3
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 |