FDA.reportPublic FDA data

ARIES® Bordetella Assay

Primary DI
00840487101452
Brand
ARIES® Bordetella Assay
Company
LUMINEX CORPORATION
Model
50-10037
Device description
The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.
Published
2017-05-09
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
K163626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163626000ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation2017-05-02OZZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101452008404871014528404871014520840487101452

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(512)381-4397support@luminexcorp.com

Regulatory Flags#

DUNS number
965476641
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
00840487101728Hypercoagulation Panel (HC) Sample Buffer30-001-00130-001-0012019-12-05
00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
00840487101940LIAISON PLEX® Respiratory Flex Assay Kit20-005-32220-005-3222024-06-20
00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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B178GBBORD100Bordetella Direct TestGREAT BASIN SCIENTIFIC, INC.OZZ2017-07-12
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
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