Duns Number:092815364
Device Description: Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! F Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples.
Catalog Number
781130
Brand Name
ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit
Version/Model Number
781130
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
K083746
Product Code
PSZ
Product Code Name
Devices Detecting Influenza A, B, And C Virus Antigens
Public Device Record Key
c17b1804-d3f5-4c0d-a5f5-130dddeee41e
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
March 12, 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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |