FDA Registration
Active
🇺🇸 United States
Immulite Analyzer
Reg #: 1036362
·
FEI: 1036362
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SCIENTIFIC SUPPLIES & TECHNOLOGY, INC.
- Registration Number
- 1036362
- FEI Number
- 1036362
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7245 N.W. 43RD ST.
- City
- Doral
- State
- FL
- ZIP
- 33166
- Country
- US
Regulatory Submissions
- 510(k) Number
- K970227
Owner / Operator
- Firm Name
- SST International Inc.
- Operator Number
- 1036362
- Address
- 7245 N.W. 43RD ST., --
- City
- Miami
- State
- FL
- Postal Code
- 33166
- Country
- US
- Correspondent
- PETER F LUE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2018-06-20 |
| Radioimmunoassay, Immunoglobulins (D, E) | JHR | Class 2 | Immunology | No | 2018-06-20 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2018-06-20 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2018-06-20 |
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2018-06-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-06-20 |
Proprietary Names
Immulite Analyzer
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device