FDA.reportPublic FDA data

AmpliVue

Primary DI
30014613312093
Brand
AmpliVue
Company
QUIDEL CORPORATION
Model
Bordetella Assay
Catalog number
M209
Device description
AmpliVue Bordetella Assay
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
OZZBordetella pertussis dna assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143206000AmpliVue Bordetella AssayQuidel Corporation2014-12-10OZZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613312093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461331209330014613312093

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Bordetella species 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 species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica 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
00875197007350cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.OZZ2026-02-23
00875197007367cobas liat Bordetella panel control kitRoche Molecular Systems, Inc.OZZ2026-02-23
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZZ2024-05-03
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZZ2023-04-06
30014613336167SolanaDIAGNOSTIC HYBRIDS, INC.OZZ2020-02-04
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OZZ2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOZZ2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOZZ2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOZZ2019-12-05
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOZZ2019-05-24
00840733102141Alethia™ Pertussis External Control KitMERIDIAN BIOSCIENCE, INC.OZZ2019-01-08
00840733102226Alethia™ PertussisMERIDIAN BIOSCIENCE, INC.OZZ2019-01-08
20816101025620Simplexa™ Bordetella DirectDIASORIN MOLECULAR LLCOZZ2018-08-24
20816101025637Simplexa™ Bordetella Positive Control PackDIASORIN MOLECULAR LLCOZZ2018-08-24
00815381020154FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOZZ2017-07-18
00815381020161FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOZZ2017-07-18
B178GBBORD100Bordetella Direct TestGREAT BASIN SCIENTIFIC, INC.OZZ2017-07-12
00840487101452ARIES® Bordetella AssayLUMINEX CORPORATIONOZZ2017-05-09
00815381020147FilmArray® Respiratory Panel (RP) EZBIOFIRE DIAGNOSTICS, LLCOZZ2016-12-06
00840733101137illumigene Pertussis External Control KitMERIDIAN BIOSCIENCE, INC.OZZ2016-09-23
00840733101199illumigene PertussisMERIDIAN BIOSCIENCE, INC.OZZ2016-09-23
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeNANOSPHERE, INC.OZZ2016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction TrayNANOSPHERE, INC.OZZ2016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification TrayNANOSPHERE, INC.OZZ2016-09-23
00815381020062FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOZZ2016-09-23
00815381020079FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOZZ2016-09-23