Duns Number:362917692
Device Description: Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Regular S Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Regular Swabs
Catalog Number
BSP-510-22-08
Brand Name
Status Flu A+B Validation Kit
Version/Model Number
BSP-510-22-08
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
Yes
Prescription Use (Rx)
-
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
cd84c7b0-9faf-4390-b986-e177ccbfe739
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 10, 2017
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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |
| U | Unclassified | 2 |