FDA Registration
Active
🇺🇸 United States
Fastep COVID-19 Antigen Pen Home Test
Reg #: 3014862351
·
FEI: 3014862351
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AZURE BIOTECH INC
- Registration Number
- 3014862351
- FEI Number
- 3014862351
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10400 Main Street
- City
- Houston
- State
- TX
- ZIP
- 77025
- Country
- US
Owner / Operator
- Firm Name
- Azure Biotech Inc
- Operator Number
- 10058544
- Address
- 10400 Main Street
- City
- Houston
- State
- TX
- Postal Code
- 77025
- Country
- US
- Correspondent
- Frank Luo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2023-11-17 |
Proprietary Names
Fastep COVID-19 Antigen Pen Home Test
Fastep COVID-19 Antigen Home Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility