Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012918440

FEI Number

3012918440

Entity Name

Meridian Bioscience Canada Inc.

City/State/Country

Quebec, CA

Establishment Address

360 Franquet, Quebec G1P4N3, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Meridian Bioscience Canada Inc. (Owner Number: 10060673)

Owner / Operator Contact Address

360 Franquet, Quebec, CA-QC G1P4N3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Revogene C. difficile Revogene System RNA Software Upgrade Kit Revogene SARS-CoV-2 Revogene GBS LB Revogene Carba C Revogene Revogene and accessories revogene check

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	Class 2	866.3130	2019-06-10
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-11-17
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-06-10
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2019-06-10
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-06-10
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony	Microbiology	Class 2	866.1640	2019-06-10
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-10-28
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-06-10
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2020-12-30

Official Correspondent

No official correspondent registered.

US Agent Details

Susan Bogar Business: Meridian Bioscience Email: susan.bogar@meridianbioscience.com Phone: (513) 2713700

Related Public Records

Same Entity

Meridian Bioscience Canada Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Similar Registrations

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
3004141078	ROCHE MOLECULAR SYSTEMS, INC.	PLEASANTON, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012918440. Last updated year: 2026. Please use registration number 3012918440 when referencing this establishment in official correspondence.