FDA Registration
Active
🇺🇸 United States
410500 revogene Carba C
Reg #: 1524213
·
FEI: 1524213
·
Expires 2025
Products
2
Proprietary Names
2
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- MERIDIAN BIOSCIENCE, INC.
- Registration Number
- 1524213
- FEI Number
- 1524213
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3471 River Hills Dr
- City
- Cincinnati
- State
- OH
- ZIP
- 45244
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190275
Owner / Operator
- Firm Name
- MERIDIAN BIOSCIENCE, INC.
- Operator Number
- 1524213
- Address
- 3471 RIVER HILLS DR., --
- City
- Cincinnati
- State
- OH
- Postal Code
- 45244
- Country
- US
- Correspondent
- Susan M Bogar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2020-04-07 |
| System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | PMY | Class 2 | Microbiology | No | 2020-04-07 |
Proprietary Names
410500 revogene Carba C
revogene Carba C
Establishment Types
Manufacture Medical Device