FDA Registration
Active
🇺🇸 United States
Genabio COVID-19 Rapid Self-Test Kit
Reg #: 3016609999
·
FEI: 3016609999
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENABIO DIAGNOSTICS INC
- Registration Number
- 3016609999
- FEI Number
- 3016609999
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 19B Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Owner / Operator
- Firm Name
- Genabio Diagnostics Inc.
- Operator Number
- 10063095
- Address
- 19B Crosby Dr. Ste 220
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- weike mo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2022-07-13 |
Proprietary Names
Genabio COVID-19 Rapid Self-Test Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility