Duns Number:251005005
Device Description: Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detect Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens.
Catalog Number
FLUab-19C15
Brand Name
Rapid Response
Version/Model Number
FLUab-19C15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041441,K041441
Product Code
GNX
Product Code Name
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Public Device Record Key
cf1d69e2-c181-4cfb-9511-6eb5bf46f5b9
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 25, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |