FDA Registration
Active
🇨🇦 Canada
Meridian Bioscience Canada Inc.
Reg #: 3012918440
·
FEI: 3012918440
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Meridian Bioscience Canada Inc.
- Registration Number
- 3012918440
- FEI Number
- 3012918440
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 360 Franquet
- City
- Quebec
- Country
- CA
Owner / Operator
- Firm Name
- Meridian Bioscience Canada Inc.
- Operator Number
- 10060673
- Address
- 360 Franquet
- City
- Quebec
- State
- CA-QC
- Postal Code
- G1P4N3
- Country
- CA
US Agent
- Business Name
- Meridian Bioscience
- Contact Name
- Susan Bogar
- Address
- 3471 River Hills Drive
- City
- Cincinnati
- State
- OH
- ZIP
- 45244
- Country
- US
- [email protected]
- Phone
- 513 2713700 ext. 10124
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| C. Difficile Toxin Gene Amplification Assay | OZN | Class 2 | Microbiology | No | 2019-06-10 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-11-17 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2019-06-10 |
| Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | NJR | Class 1 | Microbiology | No | 2019-06-10 |
| System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | PMY | Class 2 | Microbiology | No | 2019-06-10 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2020-12-30 |
| Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | PGX | Class 2 | Microbiology | No | 2019-06-10 |
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
Revogene Strep A
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)