FDA.reportPublic FDA data

SilarisTM Influenza A&B Starter Pack

Primary DI
B54010280
Brand
SilarisTM Influenza A&B Starter Pack
Company
MESA BIOTECH, INC.
Model
1028
Catalog number
1028
Device description
The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
Published
2018-03-15
Public version status
Update
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
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OZEInfluenza A And Influenza B Multiplex Nucleic Acid AssayMicrobiology2

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
B54010280PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781.652.7800sdadiagnosticstsdl@sekisuidiag
781.652.7800sdadiagnosticstsdl@sekisuidiagnostics.com

Regulatory Flags#

DUNS number
056865474
Device count
1
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
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
B54010350Sialris Influenza A&B Supplemental Pack103510352019-07-29
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
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZE2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZE2023-04-06
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.OZE2022-08-05
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
B540D20010Accula Programming CassetteMESA BIOTECH, INC.OZE2020-06-08
B540D20000Accula Dock MESA BIOTECH, INC.OCC2020-04-13
B540D20000Accula Dock MESA BIOTECH, INC.OZE2020-04-13
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OZE2020-01-10
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OCC2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOZE2019-12-05
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOCC2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOCC2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOZE2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOCC2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOZE2019-12-05
B54010290Silaris RSV Control KitMESA BIOTECH, INC.OCC2019-07-29
B54010350Sialris Influenza A&B Supplemental PackMESA 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