FDA Registration
Active
🇺🇸 United States
QUICKVUE IFOB TEST
Reg #: 2024674
·
FEI: 2024674
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- QUIDEL CORP.
- Registration Number
- 2024674
- FEI Number
- 2024674
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10165 MCKELLAR CT.
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021423
Owner / Operator
- Firm Name
- QuidelOrtho Corp.
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2005-12-01 |
Proprietary Names
QUICKVUE IFOB TEST
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device