FDA.reportPublic FDA data

Silaris Dock

Primary DI
B54010260
Brand
Silaris Dock
Company
MESA BIOTECH, INC.
Model
1026
Catalog number
1026
Device description
The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette.
Published
2018-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
B54010260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056865474
Device count
1
DM exempt
true
Lot or batch
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
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
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, LLCOZE2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZE2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZE2023-04-06
10811877011221ID NOW Influenza A & B 2 Control Swab KitAlere Scarborough, Inc.OZE2022-08-05
B540D20010Accula Programming CassetteMESA BIOTECH, INC.OZE2020-06-08
B540D20000Accula Dock MESA BIOTECH, INC.OZE2020-04-13
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OZE2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOZE2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOZE2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOZE2019-12-05
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.OZE2018-10-29
10859952006014Brand nameLIFE TECHNOLOGIES CORPORATIONOZE2018-06-02
B54010280SilarisTM Influenza A&B Starter PackMESA BIOTECH, INC.OZE2018-03-15
00857167005016ePlex SystemGENMARK DIAGNOSTICS, INC.OZE2018-01-03
00857167005023ePlex SystemGENMARK DIAGNOSTICS, INC.OZE2018-01-03
00857167005030ePlex SystemGENMARK DIAGNOSTICS, INC.OZE2017-12-29
10811877010019Alere i Influenza A & B 2Alere Scarborough, Inc.OZE2017-11-20
00875197005653cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.OZE2017-01-28
00875197005950cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.OZE2017-01-28
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeNANOSPHERE, INC.OZE2016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction TrayNANOSPHERE, INC.OZE2016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification TrayNANOSPHERE, INC.OZE2016-09-23
30014613311003LyraDIAGNOSTIC HYBRIDS, INC.OZE2016-09-15
00840487100158ARIES® Flu A/B & RSV AssayLUMINEX CORPORATIONOZE2016-09-09
10811877010804Alere™ i Influenza A & BAlere Scarborough, Inc.OZE2016-09-03
10811877010811Alere™ i Influenza A & B Control Swab KitAlere Scarborough, Inc.OZE2016-09-03