FDA.reportPublic FDA data

Silaris RSV Test

Primary DI
B54010300
Brand
Silaris RSV Test
Company
MESA BIOTECH, INC.
Model
1030
Catalog number
1030
Device description
The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chainreaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinicaland epidemiological risk factors.
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B54010300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) 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 respiratory syncytial virus (RSV) 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
B54010350Sialris Influenza A&B Supplemental Pack103510352019-07-29
B54010270Silaris Influenza A&B Test102710272018-03-15