FDA Registration
Active
🇺🇸 United States
Siro Diagnostics COVID-19 Molecular Test
Reg #: 3034617817
·
FEI: 3034617817
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Siro Diagnostics, Inc.
- Registration Number
- 3034617817
- FEI Number
- 3034617817
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9877 Waples Street
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232643
Owner / Operator
- Firm Name
- Siro Diagnostics, Inc.
- Operator Number
- 10092299
- Address
- 9877 Waples Street
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | QWB | Class 2 | Microbiology | No | 2024-12-20 |
Proprietary Names
Siro Diagnostics COVID-19 Molecular Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility