FDA Registration
Active
🇺🇸 United States
Aptiva CTD Essential Reagent
Reg #: 2026994
·
FEI: 2026994
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- INOVA DIAGNOSTICS, INC.
- Registration Number
- 2026994
- FEI Number
- 2026994
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9900 Old Grove Rd
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213403
Owner / Operator
- Firm Name
- INOVA DIAGNOSTICS, INC.
- Operator Number
- 2026994
- Address
- 9900 OLD GROVE RD., --
- City
- San Diego
- State
- CA
- Postal Code
- 92131
- Country
- US
- Correspondent
- Constance Bridges
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2023-10-05 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2023-10-05 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2023-10-05 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2023-10-05 |
| Anti-Ss-A 52 Autoantibodies | OBE | Class 2 | Immunology | No | 2023-10-05 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2023-10-05 |
| Anti-Dna Antibody, Antigen And Control | LSW | Class 2 | Immunology | No | 2023-10-05 |
Proprietary Names
Aptiva CTD Essential Reagent
Establishment Types
Manufacture Medical Device