FDA.reportPublic FDA data

Lyra

Primary DI
30014613311140
Brand
Lyra
Company
QUIDEL CORPORATION
Model
Parainfluenza Virus Assay
Catalog number
M114
Device description
Lyra Parainfluenza Assay
Published
2016-09-15
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
OOUParainfluenza multiplex nucleic acid assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOUParainfluenza Multiplex Nucleic Acid AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141927000LYRA PARAINFLUENZA VIRUS ASSAYQuidel Corporation2014-10-09OOU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613311140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461331114030014613311140

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory 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 one or multiple viruses associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
079509836
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
30014613339755Sofia 220405204052023-03-28
30014613201090QuickVueOne-Step hCG Urine Test201092016-09-15
30014613339083Sofia20374203742021-02-17
30014613339229Sofia20377203772021-02-17
30014613339373QuickVue20387203872021-02-17
30014613337799Sofia20319203192019-12-10
30014613001782QuickVue+hCG S/U Test001782016-09-14
30014613001799QuickVue+hCG S/U Test001792016-09-14
30014613003434QuickVue In-Line00343003432018-11-10
30014613201083QuickVue20108201082018-11-10
30014613201106QuickVueOne-Step hCG Combo Test201102016-09-15
30014613201229QuickVue+20122201222018-11-10
30014613201250QuickVue20125201252018-11-10
30014613201939QuickVue20193201932018-11-10
30014613202011QuickVueiFOB Test202012016-09-15
30014613202059QuickVueiFOB Test202052016-09-15
30014613202189Sofia20218202182018-11-10
30014613202424Sofia20242202422018-11-10
30014613202547Sofia20254202542018-11-10
30014613202745Sofia20274202742018-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOOU2024-05-03
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOOU2023-04-06
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OOU2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOOU2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOOU2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOOU2019-12-05
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOOU2019-05-24
00857167005016ePlex SystemGENMARK DIAGNOSTICS, INC.OOU2018-01-03
00857167005023ePlex SystemGENMARK DIAGNOSTICS, INC.OOU2018-01-03
00857167005030ePlex SystemGENMARK DIAGNOSTICS, INC.OOU2017-12-29
15420045509214Panther Fusion®Hologic, Inc.OOU2017-11-08
15420045509221Panther Fusion®Hologic, Inc.OOU2017-11-08
15420045509252Panther Fusion®Hologic, Inc.OOU2017-11-08
15420045509269Panther Fusion®Hologic, Inc.OOU2017-11-08
15420045509276Panther Fusion®Hologic, Inc.OOU2017-11-08
15420045509306Panther Fusion®Hologic, Inc.OOU2017-11-08
15420045509337Panther Fusion®Hologic, Inc.OOU2017-11-08
00815381020154FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOOU2017-07-18
00815381020161FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOOU2017-07-18
00815381020147FilmArray® Respiratory Panel (RP) EZBIOFIRE DIAGNOSTICS, LLCOOU2016-12-06
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeNANOSPHERE, INC.OOU2016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction TrayNANOSPHERE, INC.OOU2016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification TrayNANOSPHERE, INC.OOU2016-09-23
00815381020062FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOOU2016-09-23
00815381020079FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOOU2016-09-23
00840487100417NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, IncOOU2016-09-09
15420045506398PRODESSEHologic, Inc.OOU2016-04-15