FDA Registration
Active
🇭🇺 Hungary
Microbiology
Reg #: 3006198300
·
FEI: 3006198300
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Diamond Diagnostics Inc.
- Registration Number
- 3006198300
- FEI Number
- 3006198300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Oradna Street
- City
- Budapest
- Country
- HU
Regulatory Submissions
- 510(k) Number
- K160068
Owner / Operator
- Firm Name
- Diamond Diagnostics Inc.
- Operator Number
- 10028706
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- Postal Code
- 01746
- Country
- US
- Correspondent
- Kathy Fisher
US Agent
- Business Name
- DIAMOND DIAGNOSTICS INC.
- Contact Name
- Kathy Fisher
- Address
- 333 Fiske St
- City
- Holliston
- State
- MA
- ZIP
- 01746
- Country
- US
- [email protected]
- Phone
- 508 4290450 ext. 358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2024-12-27 |
| Influenza A Virus Subtype Differentiation Nucleic Acid Assay | OEP | Class 2 | Microbiology | No | 2024-12-27 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2024-12-27 |
| Non-Sars Coronavirus Multiplex Nucleic Acid Assay | OTG | Class 2 | Microbiology | No | 2024-12-27 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2024-12-27 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2024-12-27 |
| Mycoplasma Pneumoniae Dna Assay System | OZX | Class 2 | Microbiology | No | 2024-12-27 |
Proprietary Names
Microbiology
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)