Duns Number:056865474
Device Description: The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontro The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test.
Catalog Number
FAB1100CW-1
Brand Name
Accula Flu A / B Control Kit
Version/Model Number
FAB1100CW-C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K171641
Product Code
OCC
Product Code Name
Respiratory Virus Panel Nucleic Acid Assay System
Public Device Record Key
f41f4db8-2148-4c0c-b34b-babeed72b263
Public Version Date
October 25, 2022
Public Version Number
1
DI Record Publish Date
October 17, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |