Duns Number:122561087
Device Description: BD Veritor™ Plus Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rap BD Veritor™ Plus Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ System Reader (Cat. No. 256055)
Catalog Number
256070
Brand Name
BD Veritor™ Plus Laboratory Combo Pack
Version/Model Number
256070
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
-
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
GNX
Product Code Name
ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
Public Device Record Key
f5680c37-617e-47e9-89eb-f57426cf8551
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 |