FDA.reportPublic FDA data

Alethia™ Pertussis External Control Kit

Primary DI
00840733102141
Brand
Alethia™ Pertussis External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
479930
Catalog number
479930
Device description
The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors.
Published
2019-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OZZBordetella Pertussis Dna Assay System

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102141008407331021418407331021410840733102141

GMDN Terms#

Term, Definition table
TermDefinition
Bordetella pertussis nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Bordetella pertussis bacteria in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092815364
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
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

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
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
30014613312093AmpliVueQUIDEL CORPORATIONOZZ2016-09-15