DEVICE: Silaris Influenza A&B Test (B54010270)
Device Identifier (DI) Information
Silaris Influenza A&B Test
1027
In Commercial Distribution
1027
MESA BIOTECH, INC.
1027
In Commercial Distribution
1027
MESA BIOTECH, INC.
The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase
chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and
influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and
symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections
in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza
C virus.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47277 | Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus and/or influenza B virus in a clinical specimen, using a nucleic acid technique (NAT).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OCC | Respiratory Virus Panel Nucleic Acid Assay System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K171641 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2d202548-081a-46bc-aa4f-65083b671372
July 06, 2018
2
March 15, 2018
July 06, 2018
2
March 15, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined