FDA.reportPublic FDA data

Lyra

Primary DI
30014613311133
Brand
Lyra
Company
QUIDEL CORPORATION
Model
Adenovirus Assay
Catalog number
M113
Device description
Lyra Adenovirus 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
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
K141931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141931000LYRA ADENOVIRUS ASSAYQuidel Corporation2014-10-09OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613311133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461331113330014613311133

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus 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 Adenovirus in a clinical specimen, using a nucleic acid technique (NAT).

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
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
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
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