FDA Registration
Active
🇺🇸 United States
InteliSwab COVID-19 Rapid Test
Reg #: 3022474803
·
FEI: 3022474803
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORASURE TECHNOLOGIES, INC.
- Registration Number
- 3022474803
- FEI Number
- 3022474803
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2685 Opus Way, --
- City
- Bethlehem
- State
- PA
- ZIP
- 18020
- Country
- US
Owner / Operator
- Firm Name
- ORASURE TECHNOLOGIES, INC.
- Operator Number
- 9000083
- Address
- 220 EAST FIRST STREET, --
- City
- Bethlehem
- State
- PA
- Postal Code
- 18015
- Country
- US
- Correspondent
- Tiffany A Miller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-03-09 |
Proprietary Names
InteliSwab COVID-19 Rapid Test
InteliSwab COVID-19 Rapid Test Pro
InteliSwab COVID-19 Rapid Test Rx
Establishment Types
Manufacture Medical Device