FDA.reportPublic FDA data

510(k) K152285

Device
Illumigene Pertussis DNA Amplification Assay
Applicant
MERIDIAN BIOSCIENCE, INC.
510(k) number
K152285
Product code
OZZ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-11-10
Date received
2015-08-12
Regulation
866.3980
Classification name
Bordetella Pertussis Dna Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SUSAN ROLIH
Address
3471 River Hills Dr. Cincinnati OH US 45244 45244

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OZZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.2025-11-20
K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC2018-12-19
K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC2018-08-13
K181029Solana Bordetella Complete AssayQuidel Corporation2018-07-15
K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation2017-05-02
K170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc.2017-03-31
K143206AmpliVue Bordetella AssayQuidel Corporation2014-12-10
K133673ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMAMeridian Bioscience, Inc.2014-03-25

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Decision Summary