FDA Registration
Active
🇺🇸 United States
COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)
Reg #: 2025099
·
FEI: 3007981058
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biomerica
- Registration Number
- 2025099
- FEI Number
- 3007981058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17571 Von Karman Ave
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Owner / Operator
- Firm Name
- Biomerica, Inc.
- Operator Number
- 10023649
- Address
- 17571 Von Karman Ave
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-12-21 |
Proprietary Names
COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)
COVID-19 Antigen Rapid Test (Oral Fluid)
Establishment Types
Manufacture Device in the United States for Export Only