Duns Number:056865474
Device Description: The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diag The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.
Catalog Number
1027
Brand Name
Silaris Influenza A&B Test
Version/Model Number
1027
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
2d202548-081a-46bc-aa4f-65083b671372
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |