FDA Registration
Active
🇺🇸 United States
OraQuick ADVANCE Rapid HIV 1/2
Reg #: 3003297763
·
FEI: 3003297763
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORASURE TECHNOLOGIES, INC.
- Registration Number
- 3003297763
- FEI Number
- 3003297763
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 150 WEBSTER ST
- City
- Bethlehem
- State
- PA
- ZIP
- 18015
- Country
- US
Regulatory Submissions
- PMA Number
- BP010047
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 |
|---|---|---|---|---|---|
| Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test | QSU | Class 2 | Microbiology | No | 2007-11-19 |
Proprietary Names
OraQuick ADVANCE Rapid HIV 1/2
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility