FDA Registration
Active
🇭🇺 Hungary
Immunology
Reg #: 3006198300
·
FEI: 3006198300
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
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
- K141133
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 |
|---|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2024-12-27 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2024-12-27 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2024-12-27 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2024-12-27 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2024-12-27 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-12-27 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2024-12-27 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2024-12-27 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2024-12-27 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2024-12-27 |
Proprietary Names
Immunology
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)