FDA Registration
Active
🇺🇸 United States
Savanna HSV 1+2/VZV Assay
Reg #: 2024674
·
FEI: 2024674
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
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
- K232286
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 |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-01-26 |
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2024-01-26 |
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | Class 2 | Microbiology | No | 2024-01-26 |
Proprietary Names
Savanna HSV 1+2/VZV Assay
Savanna Instrument
Savanna HSV 1+2/VZV Control Set
Establishment Types
Manufacture Medical Device