FDA.reportPublic FDA data

Sialris Influenza A&B Supplemental Pack

Primary DI
B54010350
Brand
Sialris Influenza A&B Supplemental Pack
Company
MESA BIOTECH, INC.
Model
1035
Catalog number
1035
Device description
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.
Published
2019-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCCRespiratory Virus Panel Nucleic Acid Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171641000Accula Flu A/Flu B TestMesa Biotech, Inc.2018-02-06OZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B54010350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-332-1042sdadiagnosticstsdl@sekisuidiagnostics.com

Regulatory Flags#

DUNS number
056865474
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B540FAB1100CWC0Accula Flu A / B Control KitFAB1100CW-CFAB1100CW-12022-10-17
B540D20010Accula Programming CassetteD2001D20012020-06-08
B540D20000Accula Dock D2000D20002020-04-13
B54010240 Silaris Influenza A&B Control Kit102410242018-03-15
B54010260Silaris Dock102610262018-03-15
B54010280SilarisTM Influenza A&B Starter Pack102810282018-03-15
B540FAB1100CW0Accula Flu A / B TestFAB1100CWFAB1100CW2022-10-17
B540COV4100010Accula SARS CoV-2 Control KitCOV4100-1COV4100-12020-05-19
B540COV41000Accula SARS-CoV-2 TestCOV4100COV41002020-04-13
B54010400Silaris RSV Supplemental Pack104010402019-07-29
B54010290Silaris RSV Control Kit102910292019-07-29
B54010300Silaris RSV Test103010302019-07-29
B54010270Silaris Influenza A&B Test102710272018-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOCC2023-04-06
B540FAB1100CW0Accula Flu A / B TestMESA BIOTECH, INC.OCC2022-10-17
B540FAB1100CWC0Accula Flu A / B Control KitMESA BIOTECH, INC.OCC2022-10-17
10811877011221ID NOW Influenza A & B 2 Control Swab KitAlere Scarborough, Inc.OCC2022-08-05
20816101026962Simplexa™ Flu A/B & RSV Direct Gen IIDIASORIN MOLECULAR LLCOCC2020-08-29
B540D20010Accula Programming CassetteMESA BIOTECH, INC.OCC2020-06-08
B540D20000Accula Dock MESA BIOTECH, INC.OCC2020-04-13
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OCC2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOCC2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOCC2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOCC2019-12-05
B54010290Silaris RSV Control KitMESA BIOTECH, INC.OCC2019-07-29
B54010400Silaris RSV Supplemental PackMESA BIOTECH, INC.OCC2019-07-29
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOCC2019-05-24
30014613336068SolanaDIAGNOSTIC HYBRIDS, INC.OCC2018-11-16
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.OCC2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.OCC2018-10-29
10811877010521ID NOW RSVAlere Scarborough, Inc.OCC2018-10-29
10811877010538ID NOW RSV Control Swab KitAlere Scarborough, Inc.OCC2018-10-29
15415219000635Idylla™ Respiratory (IFV-RSV) PanelBiocartis NVOCC2018-10-23
30014613336143SolanaDIAGNOSTIC HYBRIDS, INC.OCC2018-08-07
B54010240 Silaris Influenza A&B Control KitMESA BIOTECH, INC.OCC2018-03-15
B54010270Silaris Influenza A&B TestMESA BIOTECH, INC.OCC2018-03-15
B54010280SilarisTM Influenza A&B Starter PackMESA BIOTECH, INC.OCC2018-03-15
07332940000783Xpert FLU/RSV XCCEPHEIDOCC2018-01-29
07332940001070Xpert FluCEPHEIDOCC2018-01-29
07332940005177Xpert Flu+RSV XpressCEPHEIDOCC2018-01-29