FDA Registration
Active
🇺🇸 United States
Flowflex COVID-19 Antigen Home Test
Reg #: 2531491
·
FEI: 3003516723
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ACON LABORATORIES, INC.
- Registration Number
- 2531491
- FEI Number
- 3003516723
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9440 Carroll Park Drive
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Owner / Operator
- Firm Name
- ACON Laboratories, Inc.
- Operator Number
- 9063887
- Address
- 5850 Oberlin Drive, #340
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Catherine Shi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-10-22 |
Proprietary Names
Flowflex COVID-19 Antigen Home Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device